BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

August 16, 2024

Study Completion Date

August 16, 2024

Conditions
Hairy Cell Leukemia
Interventions
DRUG

Vemurafenib

Patients will receive vemurafenib at a dose of 960mg orally b.i.d. continuously in cycles of 4 weeks (28 days) as outpatient. A bone marrow aspirate and/or biopsy will be performed after the first cycle for research purposes only. After the completion of the third cycle, a repeat bone marrow aspirate and/or biopsy will be performed for assessment of response and evaluation of MRD. Following the third cycle assessments, patients who achieve complete response (CR) with detectable MRD or partial response (PR) may continue with vemurafenib for up to 3 additional cycles at the treating physician's discretion (Cycles 4-6). Patients who achieve CR without MRD will be observed as part of post-treatment followup, and may be re-treated with vemurafenib after relapse (as per below). Patients who achieve no response (NR) after the initial 3 cycles of vemurafenib will be removed from the study. They will be followed every 3 months as part of posttreatment followup for a total of 12 months.

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

43210

Ohio State University, Columbus

60208

Northwestern University, Evanston

92037

Scripps Clinic, La Jolla

02115

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Northwestern University

OTHER

collaborator

Ohio State University

OTHER

collaborator

Dana-Farber Cancer Institute

OTHER

collaborator

Scripps Clinic

OTHER

collaborator

Northwell Health

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER