Recurrent Hairy Cell Leukemia Clinical Trial
Official title:
A Phase 2 Study of Venetoclax in Relapsed Classic or Variant Hairy Cell Leukemia
This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) of venetoclax. SECONDARY OBJECTIVES: I. To determine the complete remission (CR) and minimal residual disease (MRD)-negative CR rates of venetoclax in relapsed hairy cell leukemia/hairy cell leukemia variant (HCL/HCLv). II. To determine the rates of MRD-negative by blood flow cytometry with venetoclax. III. To determine the safety of venetoclax in relapsed HCL/HCLv. IV. To determine the response and CR duration and MRD-negative survival in relapsed HCL/HCLv receiving venetoclax. EXPLORATORY OBJECTIVES: I. To correlate response to TP53 mutations and other mutations, particularly for BRAF wild-type (WT) relapsed HCL/HCLv. II. To perform whole exome sequencing (WES) of relapsed HCL/HCLv samples to look for mutations, to correlate with response. OUTLINE: Patients receive venetoclax orally (PO) once daily (QD) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or aspiration on study. After completion of study treatment, patients are followed up at 30 days. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02153580 -
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT04578600 -
CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma
|
Phase 1 | |
| Active, not recruiting |
NCT04681105 -
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT00412594 -
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
|
Phase 2 | |
| Active, not recruiting |
NCT01841723 -
Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia
|
Phase 2 |