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Study identifier: NCT06965114 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia

Condition: Hairy Cell Leukemia · Recurrent Hairy Cell Leukemia · Refractory Hairy Cell Leukemia  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1/Phase 2
Planned participants84
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (4)

NCI - Center for Cancer ResearchBethesda, Maryland, United StatesRecruiting
Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesRecruiting
University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, Pennsylvania, United StatesRecruiting
University of Virginia Cancer CenterCharlottesville, Virginia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06965114