Maintenance Therapy With Brentuximab Vedotin (SGN-35) After Allogeneic Hematopoietic Cell Transplantation for Hodgkin Lymphoma and CD30+ Hematologic Malignancies
I. To determine the incidence of durable donor hematopoietic engraftment (defined by donor
T-cell chimerism > 50% at day +84 after hematopoietic cell transplantation [HCT]) after
allogeneic HCT and post-transplant brentuximab vedotin.
I. Rates of complete and partial response; incidence of acute graft-versus-host disease
(GVHD) grades II-IV and chronic GVHD; overall and progression-free survival; rates of
serious adverse events associated with brentuximab vedotin.
Patients receive brentuximab vedotin intravenously (IV) on day 1. Treatment repeats every 21
days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of durable hematopoietic engraftment defined as the achievement of > 50% donor CD3+ cell chimerism
Evaluated according to the allogeneic transplant protocol on which patients are co-enrolled, or according to institutional standard practice if no monitoring scheme is specified in the transplant protocol.
At day 84 after HCT
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|