Actively Recruiting
Phase II Study Comparing Vemurafenib Plus Obinutuzumab to Cladribine Plus Rituximab for Untreated Hairy Cell Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-26
86
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing two treatment approaches for people with previously untreated Hairy Cell Leukemia HCL. They are studying the safety and side effects of vemurafenib combined with obinutuzumab versus the standard treatment of cladribine with rituximab. The goal is to find which combination has fewer or milder side effects and to see which is better at eliminating cancer cells. Participants will be randomly assigned to one of two groups. One group will take vemurafenib by mouth twice daily in 4-week cycles for 4 cycles, with obinutuzumab infusions starting in the second cycle and continuing every 4 weeks during cycles 2 to 4. The other group will receive cladribine through an IV for 5 days and rituximab IV weekly for 8 weeks. Both treatments are given under medical supervision. During the study, participants will be closely monitored for side effects, especially serious treatment-related toxicities within 6 months. Researchers will also observe rates of complete remission and partial response over 2 years. Monitoring includes regular medical exams and treatment assessments. The study is sponsored by Memorial Sloan Kettering Cancer Center and lasts until September 2027.
CONDITIONS
Brief Title
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
Research Team
J
Jae Park, MD
M
Mark Geyer, MD
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