Trial Outcomes & Findings for A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma (NCT NCT02979522)

Last Updated: 2025-11-10

Results Overview

The recommended dose was determined after considering all safety data in phase 1 and assessing for dose limiting toxicities (DLTs) which are defined as the dose range at which less than or equal to (\<=) 1 of 6 evaluable participants experience DLT within the defined observation period (Cycle 1 + 28 days). This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

59 participants

Primary outcome timeframe

From the first dose (Cycle 1) up to Day 56 (Cycle length=28 days)

Results posted on

2025-11-10

Participant Flow

Participants with advanced stage newly diagnosed, classical CD30+ Hodgkin Lymphoma (HL) took part in the study at 14 investigative sites in the United States, Italy, Brazil and Japan from 06 September 2017 to data cut-off date: 24 September 2021. This study is ongoing for Post-Treatment Follow-Up (which includes Progression-Free Survival Follow-Up \[PFSFU\] and Overall Survival Follow-Up \[OSFU\]) and optional Long-Term Safety Follow-up.

Participants with advanced stage newly diagnosed, classical CD30+ HL received brentuximab vedotin 48 mg/m\^2 in combination with doxorubicin, vinblastine, and dacarbazine(A+AVD). Data for Phase 2 endpoints is reported for participants enrolled in Phase 2 only and for all treated in Phase 2, including Phase 1 participants.

Participant milestones

Participant milestones
Measure	Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
Overall Study STARTED	8	51
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.
Overall Study Post-Treatment Follow-up (PFSFU and OSFU)	0	28
Overall Study Particpants Ongoing in Long-Term Safety Follow-Up	8	23

Baseline Characteristics

A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Total n=59 Participants Total of all reporting groups
Age, Continuous	12.4 years STANDARD_DEVIATION 3.81 • n=5 Participants	13.9 years STANDARD_DEVIATION 2.88 • n=20 Participants	13.7 years STANDARD_DEVIATION 3.03 • n=40 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	24 Participants n=20 Participants	28 Participants n=40 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	27 Participants n=20 Participants	31 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	21 Participants n=20 Participants	23 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	26 Participants n=20 Participants	32 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=20 Participants	4 Participants n=40 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	3 Participants n=20 Participants	3 Participants n=40 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	12 Participants n=20 Participants	12 Participants n=40 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	26 Participants n=20 Participants	34 Participants n=40 Participants
Race/Ethnicity, Customized "Brown" or "Mulatto"	0 Participants n=5 Participants	9 Participants n=20 Participants	9 Participants n=40 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Region of Enrollment United States	2 Participants n=5 Participants	10 Participants n=20 Participants	12 Participants n=40 Participants
Region of Enrollment Japan	0 Participants n=5 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants
Region of Enrollment Italy	5 Participants n=5 Participants	10 Participants n=20 Participants	15 Participants n=40 Participants
Region of Enrollment Brazil	1 Participants n=5 Participants	29 Participants n=20 Participants	30 Participants n=40 Participants
Weight	45.91 kilograms (kg) STANDARD_DEVIATION 18.867 • n=5 Participants	49.91 kilograms (kg) STANDARD_DEVIATION 15.649 • n=20 Participants	49.37 kilograms (kg) STANDARD_DEVIATION 16.000 • n=40 Participants

PRIMARY outcome

Timeframe: From the first dose (Cycle 1) up to Day 56 (Cycle length=28 days)

Population: The DLT-evaluable population included participants who had received at least 1 dose of study drug therapy and experienced a DLT or no DLT during the DLT observation period. Participants who received granulocyte colony stimulating factor (G-CSF) during the DLT observation period were excluded from the DLT-Evaluable Population.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=6 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Recommended Dose of Brentuximab Vedotin in Combination With Doxorubicin, Vinblastine, and Dacarbazine in a Pediatric Population	—	48 mg/m^2

PRIMARY outcome

Timeframe: From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days)

Population: The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen).

AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Who Experienced Adverse Events (AEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy	—	100 percentage of participants

PRIMARY outcome

Timeframe: From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days)

Population: The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen).

AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, Is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, Is a congenital anomaly/birth defect, Is a medically important event.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Who Experienced Serious Adverse Events (SAEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy	—	13 percentage of participants

PRIMARY outcome

Timeframe: At end of treatment (EOT) visit 30 days after the last dose of study drug (at Month 7)

Population: Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility.

CR was defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in the statistical analysis plan (SAP) , data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Achieved a Complete Remission (CR) Per Independent Review Facility (IRF) Assessment Per International Working Group (IWG) Criteria at End of Treatment (EOT) Visit	76 percentage of participants Interval 63.0 to 86.0	75 percentage of participants Interval 60.0 to 86.0

PRIMARY outcome

Timeframe: From first dose of study drug up to Cycle 2 Day 25 (Each Cycle length=28 days)

The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans. PET negative after Cycle 2 was defined as an IRF Deauville score of (1 or 2 or 3). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Whose Disease Was Positron Emission Tomography (PET) Negative After 2 Cycles of Protocol Therapy Per IRF Assessment	90 percentage of participants	90 percentage of participants

PRIMARY outcome

Timeframe: At EOT visit 30 days after the last dose of study drug (at Month 7)

PR was defined as regression of measurable disease and no new sites as assessed by IRF as per IWG criteria. Percentage of participants in the response-evaluable population who achieved a partial response based on the IRF assessment at the EOT visit based on the IWG criteria are reported. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Achieved a Partial Remission (PR) Per IRF Assessment Per IWG Criteria at EOT Visit	12 percentage of participants Interval 5.0 to 23.0	12 percentage of participants Interval 6.0 to 20.0

PRIMARY outcome

Timeframe: At EOT visit 30 days after the last dose of study drug (at Month 7)

Overall response rate was defined as the percentage of participants with CR or PR as assessed by IRF using IWG criteria. CR was defined as the disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new diseases. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Achieved an Overall Response Rate (ORR) Per IRF Assessment Per IWG Criteria at EOT Visit	88 percentage of participants Interval 77.0 to 95.0	86 percentage of participants Interval 74.0 to 94.0

PRIMARY outcome

Timeframe: From first dose of study drug up to Cycle 6 (Each Cycle length=28 days)

Population: The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen).

This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Were Able to Complete 6 Cycles of Protocol Therapy at the Recommended Dose	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Population: The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point.

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) Conjugate Brentuximab Vedotin at Cycle 1 Day 1	—	22.6 microgram per milliliter(mcg/mL) Standard Deviation 1.51
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) Conjugate Brentuximab Vedotin at Cycle 1 Day 15	—	23.1 microgram per milliliter(mcg/mL) Standard Deviation 3.85
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) Conjugate Brentuximab Vedotin at Cycle 3 Day 1	—	26.7 microgram per milliliter(mcg/mL) Standard Deviation 3.65
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) Conjugate Brentuximab Vedotin at Cycle 3 Day 15	—	27.3 microgram per milliliter(mcg/mL) Standard Deviation 7.14
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) TAb at Cycle 1 Day 1	—	24.9 microgram per milliliter(mcg/mL) Standard Deviation 3.84
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) TAb at Cycle 1 Day 15	—	25.5 microgram per milliliter(mcg/mL) Standard Deviation 5.28
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) TAb at Cycle 3 Day 1	—	29.6 microgram per milliliter(mcg/mL) Standard Deviation 4.05
Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) TAb at Cycle 3 Day 15	—	28.1 microgram per milliliter(mcg/mL) Standard Deviation 7.45

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Monomethyl Auristatin E (MMAE) Cycle 1 Day 1	—	5.51 nanogram per milliliter (ng/ml) Standard Deviation 3.91
Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Monomethyl Auristatin E (MMAE) Cycle 1 Day 15	—	2.08 nanogram per milliliter (ng/ml) Standard Deviation 0.677
Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Monomethyl Auristatin E (MMAE) Cycle 3 Day 1	—	1.38 nanogram per milliliter (ng/ml) Standard Deviation 0.514
Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Monomethyl Auristatin E (MMAE) Cycle 3 Day 15	—	1.19 nanogram per milliliter (ng/ml) Standard Deviation 0.366

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Population: The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point.

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=7 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 3 Day 1	—	127 daymicrogram per milliliter(daymcg/mL) Standard Deviation 10.2
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 3 Day 15	—	128 daymicrogram per milliliter(daymcg/mL) Standard Deviation 34.4
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 3 Day 1	—	72.7 daymicrogram per milliliter(daymcg/mL) Standard Deviation 27.8
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 3 Day 15	—	64.8 daymicrogram per milliliter(daymcg/mL) Standard Deviation 13.5
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 1 Day 15	—	48.8 daymicrogram per milliliter(daymcg/mL) Standard Deviation 5.83
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 1 Day 1	—	80.6 daymicrogram per milliliter(daymcg/mL) Standard Deviation 13.0
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 1 Day 15	—	103 daymicrogram per milliliter(daymcg/mL) Standard Deviation 14.6
Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 1 Day 1	—	42.3 daymicrogram per milliliter(daymcg/mL) Standard Deviation 3.10

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=7 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of MMAE Cycle 1 Day 1	—	29.8 day* nanogram per milliliter (day*ng/mL) Standard Deviation 21.2
Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of MMAE Cycle 1 Day 15	—	13.1 day* nanogram per milliliter (day*ng/mL) Standard Deviation 2.99
Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of MMAE Cycle 3 Day 1	—	8.88 day* nanogram per milliliter (day*ng/mL) Standard Deviation 2.53
Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of MMAE Cycle 3 Day 15	—	7.17 day* nanogram per milliliter (day*ng/mL) Standard Deviation 2.17

SECONDARY outcome

Timeframe: Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Population: The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses.

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 1 Day 1	—	1.00 hour Interval 0.57 to 1.05
Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 1 Day 15	—	0.915 hour Interval 0.58 to 1.0
Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 3 Day 1	—	1.00 hour Interval 0.63 to 1.17
Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 3 Day 15	—	0.830 hour Interval 0.58 to 1.0
Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum Tmax of TAb at Cycle 1 Day 1	—	1.00 hour Interval 0.57 to 1.05
Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum Tmax of TAb at Cycle 1 Day 15	—	0.915 hour Interval 0.58 to 1.0

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Median Time to Reach Cmax (Tmax) of MMAE in Plasma Cycle 1 Day 1	—	44.9 hour Interval 21.1 to 69.1
Phase 1: Median Time to Reach Cmax (Tmax) of MMAE in Plasma Cycle 1 Day 15	—	43.1 hour Interval 41.2 to 45.9
Phase 1: Median Time to Reach Cmax (Tmax) of MMAE in Plasma Cycle 3 Day 1	—	48.0 hour Interval 42.3 to 66.9
Phase 1: Median Time to Reach Cmax (Tmax) of MMAE in Plasma Cycle 3 Day 15	—	48.2 hour Interval 20.8 to 67.0

SECONDARY outcome

Timeframe: At EOT visit 30 days after the last dose of study drug (at Month 7)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Who Achieved a CR Per IRF Assessment Per IWG Criteria at EOT Visit	—	88 percentage of participants Interval 47.0 to 100.0

SECONDARY outcome

Timeframe: At EOT visit 30 days after the last dose of study drug (at Month 7)

PR was defined as regression of measurable disease and no new diseases as per IWG Criteria based on IRF. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Who Achieved a PR Per IRF Assessment Per IWG Criteria at EOT Visit	—	13 percentage of participants Interval 1.0 to 53.0

SECONDARY outcome

Timeframe: At EOT visit 30 days after the last dose of study drug (at Month 7)

Overall response rate was defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria. CR was defined as the disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Who Achieved an ORR Per IRF Assessment Per IWG Criteria at EOT Visit	—	100 percentage of participants Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: From first dose of study drug up to Cycle 2 (Each Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Whose Disease Was PET Negative After 2 Cycles of Protocol Therapy Per IRF Assessment	—	88 percentage of participants Interval 47.0 to 100.0

SECONDARY outcome

Timeframe: From first dose of study drug up to Cycle 6 (Each Cycle length=28 days)

Population: This outcome measure was planned to be assessed only for participants treated in Phase 1 arm.

The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans. PET positive after Cycle 6 defined as an IRF Deauville score of (4 or 5). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Whose Disease Was PET Positive After 6 Cycles of Protocol Therapy Per IRF Assessment	—	13 percentage of participants Interval 1.0 to 53.0

SECONDARY outcome

Timeframe: Up to 7 months

Population: Immunogenicity population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment.

ATA positive was defined as participants who have a positive ATA in any postbaseline sample. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. Persistently ATA positive was defined as participants who have positive ATA in more than 2 postbaseline timepoints. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. nATA positive was defined as participants who have at least one positive nATA in any postbaseline ATA positive sample. Here, percentage of participants who were transiently or persistently ATA positive are considered as ATA positive. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Who Were Antitherapeutic Antibody (ATA) Positive, Persistently Positive or Transiently Positive, and Neutralizing Antitherapeutic Antibody (nATA) Positive Transiently ATA Positive	—	13 percentage of participants
Phase 1: Percentage of Participants Who Were Antitherapeutic Antibody (ATA) Positive, Persistently Positive or Transiently Positive, and Neutralizing Antitherapeutic Antibody (nATA) Positive Persistently ATA Positive	—	0 percentage of participants
Phase 1: Percentage of Participants Who Were Antitherapeutic Antibody (ATA) Positive, Persistently Positive or Transiently Positive, and Neutralizing Antitherapeutic Antibody (nATA) Positive nATA Positive	—	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen.

PFS per IRF:time from first dose until disease progression per IRF/death due to any cause,whichever occurred first.Participants with no objective progressive disease (PD),did not die,were still on study follow-up at time of analysis were removed from study prior to documentation of PD,PFS was censored on date of last adequate disease assessment before initiation of any non-protocol,alternative therapy.Participants who were on antitumor treatment,other than SCT/radiotherapy,censoring was at last adequate disease assessment before initiation of such alternative treatment.If participant experienced disease progression per IRF/died after initiation of antitumor treatment,other than SCT/radiotherapy,such participant was censored and not considered having PFS.Outcome measure was planned to be assessed for all participant treated at recommended dose in Phase 2.As per SAP,Phase 2 data was summarized and reported in two arms:Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Progression-free Survival (PFS)	NA months Median and 95% confidence interval (CI) was not estimable due to low number of participants with events.	NA months Median and 95% confidence interval (CI) was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 24 months

Population: The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen. For participants who do not have an objective PD and did not die at the last follow-up, EFS has been censored on the date of last adequate disease assessment.

EFS:Time from first dose until any treatment failure:PD per IRF including progression events during follow-up period,failing to complete 6 cycles of treatment due to any reason or death due to any cause,whichever occurred first.EFS per IRF were censored on last adequate disease assessment date per IRF if none of above events occur during study.Participants with antitumor treatment,other than SCT/radiotherapy as part of frontline treatment were censored at last adequate disease assessment before initiation of such alternative treatment.If a participant experienced disease progression per IRF/died after initiation of antitumor treatment,other than SCT/radiotherapy,such participant was censored,and not be considered having EFS.This outcome measure was planned to be assessed for all patients treated at recommended dose in Phase 2.As prespecified in SAP,data for Phase 2 was summarized and reported in two arms:Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Event-free Survival (EFS)	NA months Median and 95% CI was not estimable as most of the participants were censored.	NA months Median and 95% CI was not estimable as most of the participants were censored.

SECONDARY outcome

Timeframe: Up to 24 months

Population: The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen.

Overall survival was defined as time from first dose until death. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive, including study closure. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Overall Survival (OS)	NA months Median and 95% Cl was not estimable due to low number of participants with events.	NA months Median and 95% Cl was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 24 months

Population: Response Evaluable Population=Participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment (assessments based on investigator assessments or assessments based on an independent review facility). For participants who do not have an objective PD and did not die at the last follow-up, DOR has been censored on the date of last adequate disease assessment.

DOR per IRF in participants with a response (CR or PR per IRF) was defined as the time from start of the first objective tumor response (CR or PR per IRF) to the first subsequent PD or death due to any cause, whichever occurred first. For patients who did not have an objective PD, did not die and are either still on a study follow-up at the time of the analysis, or were removed from the study prior to documentation of PD, DOR has been censored on the date of last adequate disease assessment. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Duration of Response (DOR)	NA months Median and 95% confidence interval was not estimable as most of the participants were censored.	NA months Median and 95% confidence interval was not estimable as most of the participants were censored.

SECONDARY outcome

Timeframe: Up to 24 months

Population: The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen.

This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Receiving Irradiation for HL Following Study Treatment	24 percentage of participants Interval 14.0 to 37.0	25 percentage of participants Interval 14.0 to 40.0

SECONDARY outcome

Timeframe: From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days)

Population: The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen).

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Experienced AEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days)

Population: The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen).

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Experienced SAEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy	41 percentage of participants	45 percentage of participants

SECONDARY outcome

Timeframe: From first dose until 30 days after the last dose of study drug (up to 7 months)

ATA positive was defined as participants who have a positive ATA in any postbaseline sample. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. Persistently ATA positive was defined as participants who have positive ATA in more than 2 postbaseline timepoints. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. nATA positive was defined as participants who have at least one positive nATA in any postbaseline ATA positive sample. Here, percentage of participants who were transiently or persistently ATA positive are considered as ATA positive. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Were ATA Positive, Persistently Positive, or Transiently Positive, and nATA Positive Transiently ATA Positive	7 percentage of participants	6 percentage of participants
Phase 2: Percentage of Participants Who Were ATA Positive, Persistently Positive, or Transiently Positive, and nATA Positive Persistently ATA Positive	0 percentage of participants	0 percentage of participants
Phase 2: Percentage of Participants Who Were ATA Positive, Persistently Positive, or Transiently Positive, and nATA Positive nATA Positive	3 percentage of participants	4 percentage of participants

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=57 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=50 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of Brentuximab Vedotin at Cycle 1 Day 1	23.0 µg/mL Standard Deviation 5.21	23.1 µg/mL Standard Deviation 5.54
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of TAb Vedotin at Cycle 3 Day 15	31.4 µg/mL Standard Deviation 10.4	32.2 µg/mL Standard Deviation 11.0
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of TAb Vedotin at Cycle 3 Day 1	29.5 µg/mL Standard Deviation 8.44	29.5 µg/mL Standard Deviation 8.89
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of Brentuximab Vedotin at Cycle 1 Day 15	24.9 µg/mL Standard Deviation 4.97	25.3 µg/mL Standard Deviation 5.12
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of Brentuximab Vedotin at Cycle 3 Day 1	27.3 µg/mL Standard Deviation 5.82	27.4 µg/mL Standard Deviation 6.14
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of Brentuximab Vedotin at Cycle 3 Day 15	25.8 µg/mL Standard Deviation 4.81	25.4 µg/mL Standard Deviation 4.03
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of TAb Vedotin at Cycle 1 Day 1	22.4 µg/mL Standard Deviation 5.23	22.1 µg/mL Standard Deviation 5.34
Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb Cmax of TAb Vedotin at Cycle 1 Day 15	26.4 µg/mL Standard Deviation 8.52	26.5 µg/mL Standard Deviation 9.02

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=54 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=46 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Mean Plasma Cmax of MMAE Cycle 1 Day 1	5.49 ng/mL Standard Deviation 2.80	5.49 ng/mL Standard Deviation 2.62
Phase 2: Mean Plasma Cmax of MMAE Cycle 1 Day 15	2.81 ng/mL Standard Deviation 1.57	2.95 ng/mL Standard Deviation 1.66
Phase 2: Mean Plasma Cmax of MMAE Cycle 3 Day 1	1.69 ng/mL Standard Deviation 0.635	1.75 ng/mL Standard Deviation 0.643
Phase 2: Mean Plasma Cmax of MMAE Cycle 3 Day 15	1.61 ng/mL Standard Deviation 0.597	1.74 ng/mL Standard Deviation 0.599

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=57 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=50 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 1 Day 1	48.8 day*µg/mL Standard Deviation 16.3	49.7 day*µg/mL Standard Deviation 17.2
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 1 Day 15	54.0 day*µg/mL Standard Deviation 20.6	54.9 day*µg/mL Standard Deviation 22.2
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 3 Day 1	63.9 day*µg/mL Standard Deviation 18.6	62.6 day*µg/mL Standard Deviation 16.9
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of Brentuximab Vedotin at Cycle 3 Day 15	61.4 day*µg/mL Standard Deviation 11.5	60.6 day*µg/mL Standard Deviation 11.1
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 1 Day 1	77.6 day*µg/mL Standard Deviation 18.0	77.2 day*µg/mL Standard Deviation 18.6
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 1 Day 15	98.1 day*µg/mL Standard Deviation 27.0	97.3 day*µg/mL Standard Deviation 28.7
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 3 Day 1	120 day*µg/mL Standard Deviation 29.1	119 day*µg/mL Standard Deviation 30.6
Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb AUC0-15d of TAb at Cycle 3 Day 15	125 day*µg/mL Standard Deviation 24.1	124 day*µg/mL Standard Deviation 21.6

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=48 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=41 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Mean Plasma AUC0-15 of MMAE Cycle 1 Day 1	31.0 day*ng/mL Standard Deviation 16.8	31.2 day*ng/mL Standard Deviation 16.2
Phase 2: Mean Plasma AUC0-15 of MMAE Cycle 1 Day 15	17.9 day*ng/mL Standard Deviation 11.4	18.4 day*ng/mL Standard Deviation 11.9
Phase 2: Mean Plasma AUC0-15 of MMAE Cycle 3 Day 1	11.1 day*ng/mL Standard Deviation 4.93	11.5 day*ng/mL Standard Deviation 5.16
Phase 2: Mean Plasma AUC0-15 of MMAE Cycle 3 Day 15	11.3 day*ng/mL Standard Deviation 5.90	12.3 day*ng/mL Standard Deviation 6.12

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=57 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=50 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 3 Day 1	1.00 hour Interval 0.0 to 23.0	1.00 hour Interval 0.0 to 23.0
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 3 Day 15	1.00 hour Interval 0.52 to 1.5	1.00 hour Interval 0.52 to 1.5
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of TAb at Cycle 3 Day 1	1.00 hour Interval 0.0 to 23.3	1.00 hour Interval 0.0 to 23.3
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of TAb at Cycle 3 Day 15	1.00 hour Interval 0.52 to 1.5	1.00 hour Interval 0.52 to 1.5
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 1 Day 1	1.00 hour Interval 0.53 to 164.0	1.03 hour Interval 0.53 to 164.0
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of Brentuximab Vedotin at Cycle 1 Day 15	1.00 hour Interval 0.5 to 22.7	1.00 hour Interval 0.5 to 22.7
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of TAb at Cycle 1 Day 1	1.00 hour Interval 0.53 to 20.8	1.01 hour Interval 0.53 to 20.8
Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum Tmax of TAb at Cycle 1 Day 15	1.00 hour Interval 0.5 to 334.0	1.00 hour Interval 0.5 to 334.0

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=54 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=46 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Median Tmax of MMAE in Plasma Cycle 1 Day 1	44.4 hour Interval 19.7 to 72.0	44.1 hour Interval 19.7 to 72.0
Phase 2: Median Tmax of MMAE in Plasma Cycle 3 Day 1	45.3 hour Interval 20.3 to 71.7	44.9 hour Interval 20.3 to 71.7
Phase 2: Median Tmax of MMAE in Plasma Cycle 3 Day 15	46.0 hour Interval 20.0 to 71.7	45.4 hour Interval 20.0 to 71.7
Phase 2: Median Tmax of MMAE in Plasma Cycle 1 Day 15	42.9 hour Interval 20.0 to 72.0	42.9 hour Interval 20.0 to 72.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: The safety population included participants who received at least 1 dose of any drug in the A+AVD regimen.

Peripheral Neuropathy (PN) was defined by the peripheral neuropathy standardized MedDRA query (SMQ) broad search. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Who Experienced Peripheral Neuropathy, Regardless of Seriousness, From the First Dose of Protocol Therapy	19 percentage of participants	20 percentage of participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: The safety population included participants who received at least 1 dose of any drug in the A+AVD regimen. Overall number analyzed signifies participants who had peripheral neuropathy were analyzed for this outcome measure, number analyzed are participants with evaluable for the specific category.

Time to onset of first event was defined as time from first dose of study drug to onset of first treatment-emergent PN event. Time to resolution was calculated as the time from onset date to the date of resolution PN (SMQ) event. Participants with multiple resolved events were counted once at the longest time to resolution. Resolution was defined as an event outcome of resolved or resolved with sequelae. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=14 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=12 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Time to Onset and Resolution for All Peripheral Neuropathy Events Time to Resolution	1.57 weeks Interval 0.3 to 100.3	1.57 weeks Interval 0.3 to 100.3
Phase 2: Time to Onset and Resolution for All Peripheral Neuropathy Events Time to Onset	5.93 weeks Interval 0.9 to 19.9	5.93 weeks Interval 0.9 to 19.9

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Month 7)

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline Immunoglobulin G Levels at End of Treatment (EOT) Baseline	16.217 g/L Standard Deviation 5.2175	16.518 g/L Standard Deviation 5.5306
Phase 2: Immune Reconstitution-Change From Baseline Immunoglobulin G Levels at End of Treatment (EOT) Change from Baseline at EOT	-4.675 g/L Standard Deviation 4.7204	-4.822 g/L Standard Deviation 4.8964

SECONDARY outcome

Timeframe: Up to 6 months

High ATA titer was defined as participants who have at least one postbaseline ATA titer less than (\>) 25. Low ATA titer was defined as participants whose postbaseline ATA titer are all less than or equal to (\<=) 25. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants With Low and High ATA Titer Values ATA Titer low	—	13 percentage of participants
Phase 1: Percentage of Participants With Low and High ATA Titer Values ATA Titer High	—	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 months

High ATA titer was defined as participants who have at least one postbaseline ATA titer \>25. Low ATA titer was defined as participants whose postbaseline ATA titer are all \<=25. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants With Low and High ATA Titer Values ATA Titer Low	7 percentage of participants	6 percentage of participants
Phase 2: Percentage of Participants With Low and High ATA Titer Values ATA Titer High	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Cycle 1 and 3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 1	—	27.2 µg/mL Standard Deviation 3.62
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 15	—	28.3 µg/mL Standard Deviation 7.32
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 15	—	23.5 µg/mL Standard Deviation 4.17
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 1	—	23.3 µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 15	—	21.1 µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 1	—	23.1 µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 15	—	21.6 µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 1	—	22.5 µg/mL Standard Deviation 1.62

SECONDARY outcome

Timeframe: Cycle 1 and 3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 1	—	42.4 day*µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 15	—	50.0 day*µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 1	—	56.6 day*µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 15	—	63.0 day*µg/mL Standard Deviation NA The standard deviation was not estimable for one participant with event.
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 1	—	42.2 day*µg/mL Standard Deviation 3.40
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 15	—	48.6 day*µg/mL Standard Deviation 6.48
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 1	—	75.4 day*µg/mL Standard Deviation 29.46
Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 15	—	65.1 day*µg/mL Standard Deviation 15.06

SECONDARY outcome

Timeframe: Up to 24 months

CR was defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. The data is reported per ATA status as categories. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Percentage of Participants Achieving CR Per IRF Assessment Per IWG Criteria in ATA Positive and ATA Negative Participants ATA Negative who Achieved CR	—	86 percentage of participants Interval 42.0 to 100.0
Phase 1: Percentage of Participants Achieving CR Per IRF Assessment Per IWG Criteria in ATA Positive and ATA Negative Participants Transiently ATA Positive who Achieved CR	—	100 percentage of participants Interval 3.0 to 100.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: The Safety Population included participants who received at least 1 dose of any drug in the A+AVD regimen, with data available for analyses. Data is reported as per ATA positive and negative status.

This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=8 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 1: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Negative: AEs	—	7 Participants
Phase 1: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Positive: AEs	—	1 Participants
Phase 1: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Negative: SAEs	—	0 Participants
Phase 1: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Positive: SAEs	—	1 Participants

SECONDARY outcome

Timeframe: Cycle 1-3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 15	22.7 µg/mL Standard Deviation 5.72	23.3 µg/mL Standard Deviation 6.88
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 1	22.4 µg/mL Standard Deviation 2.15	22.0 µg/mL Standard Deviation 2.92
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 15	24.2 µg/mL Standard Deviation 6.07	25.6 µg/mL Standard Deviation 7.93
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 15	26.0 µg/mL Standard Deviation 4.76	25.4 µg/mL Standard Deviation 3.85
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 1	26.7 µg/mL Standard Deviation 7.34	27.8 µg/mL Standard Deviation 8.56
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 1	22.7 µg/mL Standard Deviation 5.00	22.8 µg/mL Standard Deviation 5.29
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 15	25.2 µg/mL Standard Deviation 4.91	25.4 µg/mL Standard Deviation 5.02
Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 1	27.6 µg/mL Standard Deviation 5.84	27.7 µg/mL Standard Deviation 6.14

SECONDARY outcome

Timeframe: Cycle 1-3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 15	54.8 day*µg/mL Standard Deviation 19.52	55.8 day*µg/mL Standard Deviation 20.77
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 1	64.4 day*µg/mL Standard Deviation 18.99	63.0 day*µg/mL Standard Deviation 17.10
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 3 Day 15	61.7 day*µg/mL Standard Deviation 11.81	60.9 day*µg/mL Standard Deviation 11.23
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 1	49.3 day*µg/mL Standard Deviation 14.75	51.6 day*µg/mL Standard Deviation 17.17
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 1 Day 15	46.7 day*µg/mL Standard Deviation 31.81	45.6 day*µg/mL Standard Deviation 38.87
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 1	54.6 day*µg/mL Standard Deviation 7.38	53.7 day*µg/mL Standard Deviation 10.16
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Positive: Cycle 3 Day 15	59.1 day*µg/mL Standard Deviation 9.38	57.2 day*µg/mL Standard Deviation 12.37
Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants ATA Negative: Cycle 1 Day 1	48.8 day*µg/mL Standard Deviation 16.58	49.6 day*µg/mL Standard Deviation 17.41

SECONDARY outcome

Timeframe: Up to 24 months

Population: Immunogenicity Population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment. Number analyzed is the number of participants analyzed for the specified category.

CR is defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Percentage of Participants Achieving CR Per IRF Assessment Per IWG Criteria in ATA Positive and ATA Negative Participants ATA Negative	76 percentage of participants Interval 63.0 to 87.0	75 percentage of participants Interval 60.0 to 86.0
Phase 2: Percentage of Participants Achieving CR Per IRF Assessment Per IWG Criteria in ATA Positive and ATA Negative Participants Transiently ATA Positive	75 percentage of participants Interval 19.0 to 99.0	67 percentage of participants Interval 9.0 to 99.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: The Safety Population included participants who received at least 1 dose of any drug in the A+AVD regimen. Data is reported as per ATA positive and negative status.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=59 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=51 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Negative: AEs	55 Participants	48 Participants
Phase 2: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Negative: SAEs	21 Participants	21 Participants
Phase 2: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Positive: SAEs	3 Participants	2 Participants
Phase 2: Number of ATA Positive and ATA Negative Participants With AEs and SAEs ATA Positive: AEs	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=56 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=48 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in Immunoglobulin M at the End of Treatment (EOT) Baseline	1.261 g/L Standard Deviation 0.4824	1.275 g/L Standard Deviation 0.5065
Phase 2: Immune Reconstitution-Change From Baseline in Immunoglobulin M at the End of Treatment (EOT) Change at EOT (Month 7)	-0.375 g/L Standard Deviation 0.5766	-0.345 g/L Standard Deviation 0.5942

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=57 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=49 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in Immunoglobulin A at EOT Baseline	2.671 g/L Standard Deviation 1.1879	2.708 g/L Standard Deviation 1.2379
Phase 2: Immune Reconstitution-Change From Baseline in Immunoglobulin A at EOT Change from Baseline at EOT	-0.125 g/L Standard Deviation 1.0844	-0.195 g/L Standard Deviation 1.0479

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed =number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=56 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=48 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in Tetanus at EOT Baseline	1.935 (IU)/mL Standard Deviation 3.0358	1.636 (IU)/mL Standard Deviation 2.5600
Phase 2: Immune Reconstitution-Change From Baseline in Tetanus at EOT Change from Baseline at EOT	-0.914 (IU)/mL Standard Deviation 2.2679	-0.648 (IU)/mL Standard Deviation 1.3412

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=58 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=50 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in Haemophilus Influenzae B Antibody, IgG at EOT Baseline	9.50 µg/mL Standard Deviation 25.167	10.39 µg/mL Standard Deviation 27.017
Phase 2: Immune Reconstitution-Change From Baseline in Haemophilus Influenzae B Antibody, IgG at EOT Change from Baseline at EOT	-6.03 µg/mL Standard Deviation 23.160	-7.00 µg/mL Standard Deviation 24.258

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=58 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=50 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline Poliovirus Antibodies Ratio at EOT Baseline: Type I	0.02373 ratio Standard Deviation 0.028092	0.02447 ratio Standard Deviation 0.027568
Phase 2: Immune Reconstitution-Change From Baseline Poliovirus Antibodies Ratio at EOT EOT: Type I	0.00845 ratio Standard Deviation 0.023091	0.00913 ratio Standard Deviation 0.024223
Phase 2: Immune Reconstitution-Change From Baseline Poliovirus Antibodies Ratio at EOT Baseline: Type III	0.03432 ratio Standard Deviation 0.036653	0.03641 ratio Standard Deviation 0.036709
Phase 2: Immune Reconstitution-Change From Baseline Poliovirus Antibodies Ratio at EOT EOT: Type III	0.01013 ratio Standard Deviation 0.028461	0.01141 ratio Standard Deviation 0.029889

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=56 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=48 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline Total Immunoglobulin at EOT Baseline	2045.1 mg/dl Standard Deviation 583.04	2086.6 mg/dl Standard Deviation 615.62
Phase 2: Immune Reconstitution-Change From Baseline Total Immunoglobulin at EOT Change from Baseline at EOT	-556.3 mg/dl Standard Deviation 553.97	-582.3 mg/dl Standard Deviation 565.52

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=44 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=38 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in Peripheral Blood CD34+A at EOT Baseline	3.917 µL Standard Deviation 3.8917	4.182 µL Standard Deviation 4.1227
Phase 2: Immune Reconstitution-Change From Baseline in Peripheral Blood CD34+A at EOT Change from Baseline at EOT	-1.456 µL Standard Deviation 4.3472	-1.512 µL Standard Deviation 4.7075

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=57 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=49 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in Total Lymphocyte Count at EOT Baseline	1.7408 10^9 lymphocytes/L Standard Deviation 0.91394	1.8022 10^9 lymphocytes/L Standard Deviation 0.95206
Phase 2: Immune Reconstitution-Change From Baseline in Total Lymphocyte Count at EOT Change from Baseline at EOT	0.5965 10^9 lymphocytes/L Standard Deviation 3.50121	0.6736 10^9 lymphocytes/L Standard Deviation 3.77611

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=39 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=32 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD4+CD45RA+CD197-	-0.7 percentage of CD4+ subset cells Standard Deviation 2.41	-0.7 percentage of CD4+ subset cells Standard Deviation 2.25
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Baseline: CD4+CD45RA+CD197+	46.3 percentage of CD4+ subset cells Standard Deviation 14.89	46.2 percentage of CD4+ subset cells Standard Deviation 14.44
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD4+CD45RA+CD197+	-6.8 percentage of CD4+ subset cells Standard Deviation 11.04	-7.2 percentage of CD4+ subset cells Standard Deviation 11.60
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Baseline: CD4+CD45RA-CD197-	29.0 percentage of CD4+ subset cells Standard Deviation 13.42	28.0 percentage of CD4+ subset cells Standard Deviation 12.76
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD4+CD45RA-CD197-	-5.1 percentage of CD4+ subset cells Standard Deviation 16.44	-5.0 percentage of CD4+ subset cells Standard Deviation 17.72
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Baseline: CD4+CD45RA-CD197+	22.3 percentage of CD4+ subset cells Standard Deviation 13.86	23.7 percentage of CD4+ subset cells Standard Deviation 14.33
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD4+CD45RA-CD197+	12.6 percentage of CD4+ subset cells Standard Deviation 13.21	13.0 percentage of CD4+ subset cells Standard Deviation 14.14
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT Baseline: CD4+CD45RA+CD197-	3.1 percentage of CD4+ subset cells Standard Deviation 3.22	2.9 percentage of CD4+ subset cells Standard Deviation 3.41

SECONDARY outcome

Timeframe: Baseline, EOT [Month 7]

Population: Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point.

Outcome measures

Outcome measures
Measure	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD n=39 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles.	Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD n=32 Participants Brentuximab vedotin 48 mg/m\^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days.
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Baseline: CD8+CD45RA-CD197-	40.6 percentage of CD8+ subset cells Standard Deviation 20.00	39.9 percentage of CD8+ subset cells Standard Deviation 19.32
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD8+CD45RA-CD197-	-11.0 percentage of CD8+ subset cells Standard Deviation 14.33	-11.5 percentage of CD8+ subset cells Standard Deviation 13.85
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Baseline: CD8+CD45RA-CD197+	2.3 percentage of CD8+ subset cells Standard Deviation 1.76	2.4 percentage of CD8+ subset cells Standard Deviation 1.81
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD8+CD45RA-CD197+	2.1 percentage of CD8+ subset cells Standard Deviation 3.08	1.6 percentage of CD8+ subset cells Standard Deviation 2.52
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Baseline: CD8+CD45RA+CD197-	25.8 percentage of CD8+ subset cells Standard Deviation 14.60	25.9 percentage of CD8+ subset cells Standard Deviation 15.43
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD8+CD45RA+CD197-	-6.5 percentage of CD8+ subset cells Standard Deviation 11.83	-6.0 percentage of CD8+ subset cells Standard Deviation 11.27
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Baseline: CD8+CD45RA+CD197+	30.8 percentage of CD8+ subset cells Standard Deviation 18.53	31.3 percentage of CD8+ subset cells Standard Deviation 18.00
Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT Change from Baseline at EOT: CD8+CD45RA+CD197+	15.4 percentage of CD8+ subset cells Standard Deviation 12.15	15.7 percentage of CD8+ subset cells Standard Deviation 11.48

Adverse Events

Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD

Serious events: 23 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER