Low Dose Vemurafenib and Rituximab in Hairy Cell Leukemia

Completed · Phase 2

Conditions studied: Hairy Cell Leukemia

In brief

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 facts

Study ID: NCT05388123
Run by: Scripps Health
People needed: 15
Starts: 2022-03-02
Expected to finish: 2026-04-01
Last updated by the study team: 2026-04-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥ 18 years of age
Histologically confirmed HCL that are BRAF V600E positive by IHC or NGS
Patient's must meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K
Patients can either have (1) not received any prior therapy for the disease or have had (2) failure to achieve any response to the initial purine analog-based therapy or (3) subsequent relapse after any prior therapy.
ECOG performance status of 0-2
Acceptable pre-study organ function during screening not exacerbated by Hairy Cell Leukemia. General thresholds should be a total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN, and serum creatinine ≤ 1.5x ULN
For women of childbearing potential, agreement to use acceptable methods of contraception
For men with female partners of childbearing potential, agreement to use barrier contraception
Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women.
Ability to understand and willingness to sign a written informed consent document.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if…

Pregnant or breast-feeding or intending to become pregnant during the study
Have had chemotherapy (including purine analogs), rituximab, and other investigational agents within six weeks prior to entering the study. The patients cannot have received BRAF inhibitor therapy within 6 months of entering the study.
Major surgery within 4 weeks prior to entering the study
Invasive malignancy within the past 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, melanoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years
Active HIV, hepatitis B and hepatitis C or any clinically significant history of liver disease. Hepatitis B prior infection is not a contraindication though will require therapy.
Known hypersensitivity to any of the study drugs
Patients with HCL that are BRAF V600E mutation negative

Where it is running

Scripps Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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