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.
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Given IV
Correlative studies
Correlative studies
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
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.
Time frame: At day 84 after HCT
Rates of relapse
Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma.
Time frame: Up to 5 years
Non-relapse mortality
Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma.
Time frame: Up to 5 years
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
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