NCT06561360

A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)

A Randomized, Multi-Center, Phase II Study of Vemurafenib Plus Obinutuzumab vs. Cladribine Plus Rituximab in Patients With Previously Untreated Hairy Cell Leukemia (HCL)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.

Conditions

• Hairy Cell Leukemia

Interventions

Type	Name	Description
DRUG	Vemurafenib	Vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.
DRUG	Obinutuzumab	Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks.
DRUG	Cladribine	Cladribine IV on days 1-5 concurrently with rituximab.
DRUG	Rituximab	Rituximab on days 1-5 concurrently with rituximab.

Timeline

• Start date: 2024-09-09
• Primary completion: 2027-09-09
• Completion: 2027-09-09
• First posted: 2024-08-20
• Last updated: 2026-04-15

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study