Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Patients who have received prior venetoclax

Patients who are receiving any other investigational agents

History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax

Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Venetoclax

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

21
California
City of Hope Comprehensive Cancer Center91010, Duarte United States
City of Hope at Irvine Lennar92618, Irvine United States
Florida
UM Sylvester Comprehensive Cancer Center at Aventura33180, Aventura United States
UM Sylvester Comprehensive Cancer Center at Coral Gables33146, Coral Gables United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov