Brentuximab Vedotin After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase I/II trial studies the side effects and best way to give brentuximab vedotin and to see how well it works after donor stem cell transplant in treating patients with hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Monoclonal antibodies may kill cancer cells that are left after donor stem cell transplant.
Drug: brentuximab vedotin
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Peak grade of acute GVHD [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Incidence of chronic GVHD [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Severity of chronic GVHD [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||June 2017 (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.
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: David G. Maloney 206-667-5616|
|Principal Investigator: David G. Maloney|
|Principal Investigator:||David Maloney||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|