Trial Outcomes & Findings for Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT01508312)

NCT ID: NCT01508312

Last Updated: 2025-10-21

Results Overview

Following salvage therapy with brentuximab vedotin (SGN-35) alone or followed by augmented ICE chemotherapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-10-21

Participant Flow

Participant milestones

Measure	Cohort 1: FDG-PET Abnormal Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 1: FDG-PET Normalization Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Abnormal Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Normalization Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.
Overall Study STARTED	33	12	14	6
Overall Study COMPLETED	32	11	10	6
Overall Study NOT COMPLETED	1	1	4	0

Reasons for withdrawal

Measure	Cohort 1: FDG-PET Abnormal Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 1: FDG-PET Normalization Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Abnormal Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Normalization Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Participant's Hodgkin's lymphoma relapsed, proven by a biopsy sample.	0	1	0	0
Overall Study Adverse Event	0	0	2	0
Overall Study Lack of Efficacy	0	0	1	0
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	Cohort 1: FDG-PET Abnormal n=33 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 1: FDG-PET Normalization n=12 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Abnormal n=14 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Normalization n=6 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Total n=65 Participants Total of all reporting groups
Age, Continuous	31 years n=5 Participants	37 years n=7 Participants	33 years n=5 Participants	39 years n=4 Participants	33 years n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	34 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	31 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	6 Participants n=4 Participants	58 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	6 Participants n=4 Participants	58 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment United States	33 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	6 Participants n=4 Participants	65 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 months

Following salvage therapy with brentuximab vedotin (SGN-35) alone or followed by augmented ICE chemotherapy.

Outcome measures

Measure	Cohort 1: FDG-PET Abnormal n=33 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 1: FDG-PET Normalization n=12 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Abnormal n=14 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Normalization n=6 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.
FDG-PET/CT Standardized Uptake Value at 12 Months	69 Standardized Uptake Value (SUV) Interval 53.0 to 85.0	27 Standardized Uptake Value (SUV) Interval 13.0 to 40.0	69 Standardized Uptake Value (SUV) Interval 39.0 to 91.0	30 Standardized Uptake Value (SUV) Interval 12.0 to 54.0

SECONDARY outcome

Timeframe: 2 years

Overall Response Rate (CR and PR rate) to brentuximab vedotin alone

Outcome measures

Measure	Cohort 1: FDG-PET Abnormal n=33 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 1: FDG-PET Normalization n=12 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Abnormal n=14 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Normalization n=6 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.
Overall Response Rate Complete Response/CR	13 Participants	0 Participants	4 Participants	0 Participants
Overall Response Rate No CR	20 Participants	12 Participants	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Cohort 1: FDG-PET Abnormal n=33 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 1: FDG-PET Normalization n=12 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Abnormal n=14 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	Cohort 2, Expansion Cohort: FDG-PET Normalization n=6 Participants Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.
Participants Evaluated for Toxicity	33 Participants	12 Participants	14 Participants	6 Participants

Adverse Events

FDG-PET Abnormal

Serious events: 21 serious events

Other events: 47 other events

Deaths: 3 deaths

FDG-PET Normalization

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	FDG-PET Abnormal n=47 participants at risk Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	FDG-PET Normalization n=18 participants at risk Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.
Gastrointestinal disorders Nausea/Vomiting	4.3% 2/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hypoglycemia	4.3% 2/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hypocalcemia	2.1% 1/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hypomagnesemia	2.1% 1/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Blood and lymphatic system disorders Febrile neutropenia	44.7% 21/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Infections and infestations Infection: Anorectal	4.3% 2/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Infections and infestations Infection: Skin	2.1% 1/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Nervous system disorders PML/Progressive multifocal leukoencephalopathy	2.1% 1/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Skin and subcutaneous tissue disorders Rash	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	5.6% 1/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations Hyperglycemia	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	11.1% 2/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
General disorders Fever	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	5.6% 1/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Gastrointestinal disorders Abdominal Pain	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	5.6% 1/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Nervous system disorders Mental status change	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	5.6% 1/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention

Other adverse events

Measure	FDG-PET Abnormal n=47 participants at risk Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.	FDG-PET Normalization n=18 participants at risk Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.
General disorders Fatigue	63.8% 30/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	77.8% 14/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations Hyperglycemia	66.0% 31/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	66.7% 12/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations AST increase	59.6% 28/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	66.7% 12/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations ALT increase	57.4% 27/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	72.2% 13/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Skin and subcutaneous tissue disorders Rash	55.3% 26/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	77.8% 14/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Nervous system disorders Neuropathy	46.8% 22/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	33.3% 6/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations Alk Phos increased	38.3% 18/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	22.2% 4/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Gastrointestinal disorders Constipation	29.8% 14/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	38.9% 7/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations White blood cell decreased	29.8% 14/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	27.8% 5/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Gastrointestinal disorders Nausea	27.7% 13/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	38.9% 7/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Respiratory, thoracic and mediastinal disorders Cough	21.3% 10/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Gastrointestinal disorders Diarrhea	21.3% 10/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	22.2% 4/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Skin and subcutaneous tissue disorders Pruritus	21.3% 10/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	66.7% 12/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Skin and subcutaneous tissue disorders Alopecia	19.1% 9/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations Platelet count decreased	17.0% 8/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	27.8% 5/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hypernatremia	14.9% 7/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	11.1% 2/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Respiratory, thoracic and mediastinal disorders Dyspnea	10.6% 5/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	11.1% 2/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Musculoskeletal and connective tissue disorders Arthralgia	10.6% 5/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Musculoskeletal and connective tissue disorders Myalgia	10.6% 5/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations Neutrophil count decreased	10.6% 5/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	11.1% 2/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Investigations Lymphocyte count decreased	10.6% 5/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	0.00% 0/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Gastrointestinal disorders Gastroesophageal reflux	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Gastrointestinal disorders Vomiting	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/47 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention	16.7% 3/18 • 2 years Cohort 1: FDG-PET Abnormal and Cohort 2: Expansion Cohort: FDG-PET Abnormal received the same intervention. Cohort 1: FDG-PET Normalization and Cohort 2, Expansion Cohort: FDG-PET Normalization received the same intervention

Additional Information

Dr. Alison Moskowitz

Memorial Sloan Kettering Cancer Center

Phone: 212-639-4839

Email: moskowia@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place