Brentuximab Vedotin After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|Hematopoietic/Lymphoid Cancer||Drug: brentuximab vedotin Other: laboratory biomarker analysis Other: pharmacological study||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Maintenance Therapy With Brentuximab Vedotin (SGN-35) After Allogeneic Hematopoietic Cell Transplantation for Hodgkin Lymphoma and CD30+ Hematologic Malignancies|
- Incidence of durable hematopoietic engraftment defined as the achievement of > 50% donor CD3+ cell chimerism [ Time Frame: At day 84 after HCT ]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.
- Rates of relapse [ Time Frame: Up to 5 years ]Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma.
- Non-relapse mortality [ Time Frame: Up to 5 years ]Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma.
- Incidence of acute GVHD [ Time Frame: Up to 5 years ]
- Peak grade of acute GVHD [ Time Frame: Up to 5 years ]
- Incidence of chronic GVHD [ Time Frame: Up to 5 years ]
- Severity of chronic GVHD [ Time Frame: Up to 5 years ]
- Incidence of adverse events related to brentuximab vedotin, graded according to National Cancer Institute Common Toxicity Criteria version 4 [ Time Frame: Up to 30 days after completion of study treatment ]
|Study Start Date:||June 2013|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (brentuximab vedotin)
Patients receive brentuximab vedotin IV on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
Drug: brentuximab vedotin
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
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 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620229
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||David Maloney||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|