Actively Recruiting
Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
84
Participants Needed
4
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial tests the safety, side effects, and effectiveness of tovorafenib in combination with rituximab in patients with classical hairy cell leukemia (cHCL) that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory) and compares the effect of tovorafenib and rituximab to current standard treatment of cladribine and rituximab in cHCL patients that have not yet received treatment. Tovorafenib blocks certain proteins made by the mutated BRAF gene, which may help keep cancer cells from growing. It is a type of kinase inhibitor. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cladribine damages the cell's deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Giving tovorafenib in combination with rituximab may be safe and tolerable and more effective than cladribine with rituximab in treating patients with untreated, recurrent or refractory cHCL.
CONDITIONS
Official Title
Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of classical hairy cell leukemia (cHCL) with BRAF V600E mutation
- For phase 1: prior therapy with at least one purine nucleoside analog unless contraindicated
- For phase 2: no prior treatment for cHCL (treatment-naive)
- Age 18 years or older
- Indications for treatment including low neutrophil count, low platelets, low hemoglobin, recurrent infections, symptomatic disease, and specific constitutional symptoms
- ECOG performance status 2 or less (Karnofsky 60% or higher), or higher if due to cHCL
- Total bilirubin less than or equal to 1.5 times upper limit of normal
- AST/ALT less than or equal to 3 times institutional upper limit of normal unless related to Gilbert's disease or cHCL
- Creatinine clearance 30 mL/min or higher
- HIV patients on effective therapy with undetectable viral load within 6 months
- For chronic hepatitis B, undetectable viral load on suppressive therapy if needed
- Hepatitis C patients treated and cured or on treatment with undetectable viral load for more than 6 months
- Patients with prior or concurrent malignancies not interfering with study
- ECG without significant arrhythmias or ischemia and QTc less than 480 msec
- Women of child-bearing potential and men must agree to use two forms of contraception during and 12 months after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Central nervous system involvement with hairy cell leukemia except treated brain metastases with no progression
- Patients without BRAF V600E mutation or with variant hairy cell leukemia
- Platelet count less than 50,000/mcL
- Use of warfarin or direct oral anticoagulants
- Unrecovered toxicities from prior anticancer therapy greater than grade 1 except alopecia
- Receiving other investigational agents
- Receiving strong CYP2C8 inhibitors, inducers, or certain narrow therapeutic index substrates
- Pregnant, breastfeeding, or unwilling to use contraception during and 12 months after study
- History of allergic reactions to study drugs or severe infusion reactions to rituximab
- Known hypersensitivity to any study drugs
- Unable to swallow oral medications or with gastrointestinal impairment
- Live or live-attenuated vaccines within 28 days before randomization
- Uncontrolled illnesses or conditions making participation unsafe
- Pregnant or breastfeeding women due to potential risks of study drugs
AI-Screening
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Trial Site Locations
Total: 4 locations
1
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
3
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
4
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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