RecruitingPhase 1Phase 2NCT06965114

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

A Phase 1 Study of Combination Tovorafenib (DAY101) and Rituximab Treatment in Relapsed or Refractory Classical Hairy Cell Leukemia and Phase 2 Randomized Study Comparing Tovorafenib (DAY101) and Rituximab With Cladribine and Rituximab for Front-Line Treatment of Classical Hairy Cell Leukemia

Sponsor

National Cancer Institute (NCI)

Enrollment

84 participants

Start Date

Jun 27, 2026

Study Type

INTERVENTIONAL

Conditions

Hairy Cell Leukemia Recurrent Hairy Cell Leukemia Refractory Hairy Cell Leukemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of tovorafenib (a targeted therapy) and rituximab (an immunotherapy) for people with hairy cell leukemia — a rare, slow-growing blood cancer — to see if this combination works better than existing treatments, especially for those whose cancer has come back. **You may be eligible if...** - You have a confirmed diagnosis of classic hairy cell leukemia with the BRAF V600E mutation - For Phase 1: You have previously received at least one standard chemotherapy regimen (unless medically unable to) - For Phase 2: You may be newly diagnosed or have relapsed/refractory disease **You may NOT be eligible if...** - You have an active serious infection including HIV or active hepatitis B/C - You have significant heart, kidney, or liver problems - You have had certain other recent cancer treatments 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

PROCEDUREBiospecimen Collection

Undergo blood sample and buccal swab collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

DRUGCladribine

Given IV

PROCEDUREComputed Tomography

Undergo CT

BIOLOGICALRituximab

Given IV

DRUGTovorafenib

Given PO

Locations(4)

NCI - Center for Cancer Research

Bethesda, Maryland, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06965114

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