Trial Outcomes & Findings for A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression (NCT NCT04569032)

Last Updated: 2025-12-30

Results Overview

ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months

Results posted on

2025-12-30

Participant Flow

Participants who had newly diagnosed non-systemic anaplastic large cell lymphoma (sALCL) peripheral T-cell lymphoma (PTCL) with \< 10% CD30 expression, were enrolled to receive A+CHP treatment (brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone). Enrollment was based on CD30 expression per local laboratory assessment. Analysis of efficacy outcome measures was based on CD30 expression per central laboratory assessment.

Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.

Participant milestones

Participant milestones
Measure	CD30 <1% [Local Laboratory Assessment] Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Local Laboratory Assessment] Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
Overall Study STARTED	34	48
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	34	48

Reasons for withdrawal

Reasons for withdrawal
Measure	CD30 <1% [Local Laboratory Assessment] Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Local Laboratory Assessment] Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
Overall Study Death	10	13
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	0	1
Overall Study In long term follow up	22	34

Baseline Characteristics

A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CD30 <1% [Local Laboratory Assessment] n=34 Participants Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Local Laboratory Assessment] n=48 Participants Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	Total n=82 Participants Total of all reporting groups
Age, Continuous	60.2 Years STANDARD_DEVIATION 11.3 • n=174 Participants	61.0 Years STANDARD_DEVIATION 11.0 • n=166 Participants	60.7 Years STANDARD_DEVIATION 11.1 • n=167 Participants
Sex: Female, Male Female	10 Participants n=174 Participants	26 Participants n=166 Participants	36 Participants n=167 Participants
Sex: Female, Male Male	24 Participants n=174 Participants	22 Participants n=166 Participants	46 Participants n=167 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=174 Participants	10 Participants n=166 Participants	19 Participants n=167 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=174 Participants	34 Participants n=166 Participants	56 Participants n=167 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=174 Participants	4 Participants n=166 Participants	7 Participants n=167 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Asian	2 Participants n=174 Participants	4 Participants n=166 Participants	6 Participants n=167 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Black or African American	2 Participants n=174 Participants	2 Participants n=166 Participants	4 Participants n=167 Participants
Race (NIH/OMB) White	26 Participants n=174 Participants	37 Participants n=166 Participants	63 Participants n=167 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=174 Participants	5 Participants n=166 Participants	9 Participants n=167 Participants

PRIMARY outcome

Timeframe: At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months

Population: Full analysis set (FAS) included all participants who received any amount of brentuximab vedotin or any component of cyclophosphamide, doxorubicin, and prednisone (CHP). Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.

Outcome measures

Outcome measures
Measure	CD30 <1% [Central Laboratory Assessment] n=23 Participants Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Central Laboratory Assessment] n=31 Participants Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment	61 Percentage of participants Interval 38.5 to 80.3	81 Percentage of participants Interval 62.5 to 92.5

SECONDARY outcome

Timeframe: At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months

Population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.

CR rate was defined as the percentage of participants with CR following the completion of study treatment (at EOT). CR as per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

Outcome measures

Outcome measures
Measure	CD30 <1% [Central Laboratory Assessment] n=23 Participants Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Central Laboratory Assessment] n=31 Participants Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment	52 Percentage of participants Interval 30.6 to 73.2	71 Percentage of participants Interval 52.0 to 85.8

SECONDARY outcome

Timeframe: From the first dose of study treatment to first documentation of objective tumor progression or death due to any cause or censoring, whichever came first (approximately 61.7 months)

PFS was defined as the time from start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever came first. Kaplan-Meier method was used for analysis. PFS data was censored on the date of the last radiological assessment of measured lesions documenting absence of PD for participants without objective tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment or stem cell transplant (included donor lymphocyte infusion) or were removed from study prior to documentation of objective tumor progression. Participants who lacked an evaluation of tumor response after their first dose had their event time censored at 1 day.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months)

OS was defined as the time from first dose to death due to any cause. Participant not known to have died by the end of study follow-up, observation of OS was censored on the date the participants were last known to be alive (i.e., date of last contact). Participants who lacked data beyond the day of first dose had their survival time censored on the date of first dose (i.e., OS duration of 1 day). Kaplan-Meier method was used for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first documented CR or PR until the first documentation of tumor progression, death or censoring date, whichever came first (up to 61.7 months)

DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (per Cheson 2007) or death, whichever came first. Participants without progression or death were censored. DOR was only calculated for the subset of participants achieving a CR or PR. CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Kaplan-Meier method was used for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months

ORR was defined as the percentage of participants with CR or PR following the completion of study treatment (at EOT) according to the modified Lugano criteria (Cheson 2014). Complete response was defined as complete disappearance of radiologic evidence of disease and PR was defined as at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses.

Outcome measures

Outcome measures
Measure	CD30 <1% [Central Laboratory Assessment] n=23 Participants Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Central Laboratory Assessment] n=31 Participants Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment	57 Percentage of participants Interval 34.5 to 76.8	77 Percentage of participants Interval 58.9 to 90.4

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)

Population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP.

An adverse event was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An adverse event was classified as a serious adverse event (SAE) if it met one of the following criteria: fatal, life threatening, hospitalization, disabling/incapacitating, congenital anomaly or birth defect or any medically significant event. TEAEs were events if they were newly occurring or worsen following study treatment. TESAE is any SAE that met treatment emergent definition. Treatment related AEs were which had evidence to suggest a causal relationship between the drugs and the adverse event, such as: an event that was uncommon and known to be strongly associated with drug exposure, an event that was not commonly associated with drug exposure but was otherwise uncommon in the population exposed to the drug. AEs included both SAEs and all non-SAEs.

Outcome measures

Outcome measures
Measure	CD30 <1% [Central Laboratory Assessment] n=34 Participants Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Central Laboratory Assessment] n=48 Participants Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment TEAEs	32 Participants	46 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment TESAEs	15 Participants	16 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment Treatment related TEAEs	25 Participants	40 Participants

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)

Population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Here, "Overall Number of Participants Analyzed" were participants evaluable for this outcome measure however all participants reported under "Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for the specified rows.

Any Abnormal laboratory tests(Decreased values of hemoglobin,leukocytes,lymphocytes,neutrophils, platelets, calcium corrected for albumin,glomerular filtration rate estimated, glucose, phosphate, potassium,albumin,sodium and increased values of calcium corrected for albumin,creatinine, potassium, glucose, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total Bilirubin, urate) that worsen from baseline were considered clinically significant by investigator.Abnormal test were recorded as AE if associated with accompanying symptoms,required additional diagnostic testing or medical/surgical intervention,study dosing change,study discontinuation,significant additional concomitant drug treatment,other therapy.As perNCI CTCAE grade(G)1:mild(asymptomatic or mild symptoms,clinical,diagnostic observations,no intervention),G2:moderate(minimal, local,noninvasive intervention),G3:severe,medically significant,G4:life-threatening,urgent intervention,G5:death related to AE

Outcome measures

Outcome measures
Measure	CD30 <1% [Central Laboratory Assessment] n=34 Participants Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	CD30 1% to <10% [Central Laboratory Assessment] n=48 Participants Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Hemoglobin decreased: Grade 1+2	19 Participants	34 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Hemoglobin decreased: Grade 3	3 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Leukocytes decreased: Grade 1+2	13 Participants	23 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Leukocytes decreased: Grade 3	4 Participants	5 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Leukocytes decreased: Grade 4	0 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Lymphocytes decreased: Grade 1+2	10 Participants	15 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Lymphocytes decreased: Grade 3	15 Participants	21 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Lymphocytes decreased: Grade 4	1 Participants	4 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Neutrophils decreased: Grade 1+2	3 Participants	12 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Neutrophils decreased: Grade 3	4 Participants	3 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Neutrophils decreased: Grade 4	1 Participants	3 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Platelets decreased: Grade 1+2	6 Participants	10 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Platelets decreased: Grade 4	0 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Calcium Corrected for Albumin increased: Grade 1+2	3 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Creatinine increased: Grade 1+2	19 Participants	30 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Glomerular Filtration Rate, Estimated decreased: Grade 1+2	2 Participants	4 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Glucose decreased: Grade 1+2	1 Participants	5 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Glucose increased: Grade 1+2	15 Participants	21 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Glucose increased: Grade 3	3 Participants	0 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Glucose increased: Grade 4	0 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Phosphate decreased: Grade 1+2	1 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Phosphate decreased: Grade 3	0 Participants	4 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Potassium decreased: Grade 1+2	2 Participants	5 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Potassium decreased: Grade 3	1 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Potassium decreased: Grade 4	0 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Alanine Aminotransferase increased: Grade 1+2	6 Participants	17 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Albumin decreased: Grade 1+2	3 Participants	8 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Alkaline Phosphatase increased: Grade 1+2	2 Participants	11 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Alkaline Phosphatase increased: Grade 3	2 Participants	0 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Aspartate Aminotransferase increased: Grade 1+2	8 Participants	15 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Aspartate Aminotransferase increased: Grade 3	0 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Calcium Corrected for Albumin decreased: Grade 1+2	2 Participants	2 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Potassium increased: Grade 1+2	2 Participants	4 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Potassium increased: Grade 3	1 Participants	0 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Sodium decreased: Grade 1+2	8 Participants	6 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Sodium decreased: Grade 3	1 Participants	3 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Sodium increased: Grade 1+2	0 Participants	2 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Total Bilirubin increased: Grade 1+2	1 Participants	1 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Urate increased: Grade 3	4 Participants	6 Participants
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment Urate increased: Grade 4	2 Participants	0 Participants

Adverse Events

CD30 <1% [Local Laboratory Assessment]

Serious events: 15 serious events

Other events: 31 other events

Deaths: 11 deaths

CD30 1% to <10% [Local Laboratory Assessment]

Serious events: 16 serious events

Other events: 43 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER