Low Dose Vemurafenib and Rituximab in Hairy Cell Leukemia

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Health
Study ID
NCT05388123
Phase
PHASE2
Status
Completed

Conditions

  • Hairy Cell Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Low dose vemurafenib plus rituximab — DRUG
    Vemurafenib 240 mg twice daily for 8 weeks with concurrent rituximab 375 mg/m2 every 2 weeks followed by maintenance consolidative rituximab 4 times every 2 weeks post-vemurafenib

Study Details

The current standard-of-care for Hairy Cell Leukemia involves chemotherapy, with agents such as cladribine or pentostatin. Chemotherapy is associated with infection, low blood counts and predisposition to future cancers. This study tests a new yet previously validated drug combination for the treatment of hairy cell leukemia. The treatment involves 8 weeks of treatment with an oral drug called vemurafenib and 8 doses of an intravenous medication called rituximab. The goal of this study is to see whether this treatment is better tolerated and more effective than the currently used treatment in this disease. In addition, this study uses a lower dose of vemurafenib than previous studies have used, with the goal of minimizing side effects from this medication.

Key Dates

Start date
Mar 2, 2022
Status verified
Apr 2026
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low dose Vemurafenib and Rituximab
    Eligible patients will receive vemurafenib at a dose of 240 mg orally twice daily (b.i.d.) continuously for 8 weeks. Rituximab 375 mg/m2 will be administered every 2 weeks for a total of 16 weeks. The entire duration of treatment will be 16 weeks.

Primary Outcome Measure

Complete Response [ Time Frame: Up to 2 years from enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps Cancer CenterLa JollaCalifornia92037-

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By research site
Scripps Cancer Center· La Jolla, CA

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