Phase 2 Study of Venetoclax for Adults with Relapsed Classic or Variant Hairy Cell Leukemia

What this Trial Is About

Researchers are evaluating how well venetoclax works in treating patients with relapsed hairy cell leukemia or its variant. This phase II trial focuses on patients whose disease has returned after previous improvement and aims to measure the response rates, including complete remission and minimal residual disease-negative status. The study also explores how genetic mutations may relate to treatment response and evaluates the safety of venetoclax in this patient group. Participants receive venetoclax by mouth once daily on days 1 through 28 of each 28-day cycle. Treatment may continue for up to 19 cycles unless the disease progresses or unacceptable side effects occur. During the study, patients undergo imaging scans like CT or MRI and blood tests regularly. Bone marrow biopsies or aspirations may also be performed, and those with central nervous system involvement may have lumbar punctures throughout the trial. Participants are monitored closely with various tests including blood samples, imaging, and possibly bone marrow and cerebrospinal fluid assessments. After finishing treatment, patients have a follow-up visit at 30 days to assess outcomes. Researchers measure the objective response rate up to 30 days after the last dose, along with remission rates, minimal residual disease status, duration of response, and safety events over this period.

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia