Venetoclax for the Treatment of Patients With Relapsed 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 f
| Condition(s) | Recurrent Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia Variant |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * Patients must have histologically or cytologically confirmed HCL/HCLv after purine analog therapy who are relapsed from or are ineligible for BRAF therapy and have not received prior venetoclax * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) unless consistent with Gilbert's (ration between total and direct bilirubin \> 5) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN * Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 45 mL/min/1.73m\^2 * Human immunodeficiency virus (HIV)-infected patients on effective ant |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | National Cancer Institute (NCI) |
| Locations | Duarte, California, United States; Irvine, California, United States; Aventura, Florida, United States; Coral Gables, Florida, United States; Coral Springs, Florida, United States; Deerfield Beach, Florida, United States (+15 more sites) |
| Start date | 2024-12-16 |
| NCT ID | NCT06311227 |
| Official listing | https://clinicaltrials.gov/study/NCT06311227 |