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

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

January 5, 2012

Primary Completion Date

March 14, 2024

Study Completion Date

March 14, 2024

Conditions
Hodgkin's Lymphoma
Interventions
DRUG

brentuximab vedotin (SGN-35)

Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with persistent abnormalities on FDG-PET/CT following 2 cycles of brentuximab vedotin will receive 2 cycles of augmented ICE. The first cycle of augmented ICE will be initiated 7-14 days after the last dose of SGN-35. FDG-PET/CT will be repeated within 7-14 days following the second cycle of augmented ICE. Stem cell mobilization can be performed following the first or second cycle of augmented ICE.

DRUG

Brentuximab Vedotin (SGN-35)

Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. Patients with normalization of FDG-PET/CT and negative bone marrow biopsies following 2 cycles of brentuximab vedotin will undergo stem cell mobilization in preparation for ASCT.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
collaborator

Seagen Inc.

INDUSTRY

collaborator

Hôpitaux Universitaires Henri Mondor, France

UNKNOWN

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01508312 - Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma | Biotech Hunter | Biotech Hunter