RecruitingPhase 2NCT06561360

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)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

86 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Hairy Cell Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment combinations for people with hairy cell leukemia (HCL) who have never been treated before — one group receives vemurafenib plus obinutuzumab (targeted therapy plus an antibody), while the other receives cladribine plus rituximab (the current standard treatment) — to see which works better. **You may be eligible if...** - You are 18 or older with a confirmed new diagnosis of classical hairy cell leukemia - Your tumor has the BRAF V600E mutation - You have not received any prior HCL treatment - Your blood counts meet the standard criteria for needing treatment **You may NOT be eligible if...** - You have active hepatitis B or C or HIV - You have a known liver disease or cirrhosis - You have a genetic heart rhythm condition (long QT syndrome) - You are pregnant or breastfeeding - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVemurafenib

Vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.

DRUGObinutuzumab

Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks.

DRUGCladribine

Cladribine IV on days 1-5 concurrently with rituximab.

DRUGRituximab

Rituximab on days 1-5 concurrently with rituximab.

Locations(10)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Ohio State University

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06561360

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