RecruitingPhase I/IIEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzona diagnoza białaczki włochatek z mutacją genu BRAF
  • Wiek minimum 18 lat
  • Faza 1: Wcześniejsze leczenie lekami podobnymi do puryny (chyba że niemożliwe)
  • Faza 2: Pacjenci bez wcześniejszego leczenia tej choroby
  • Niskie liczby komórek krwi lub objawy wymagające leczenia
  • Dobry ogólny stan zdrowia (ECOG ≤ 2)
  • Prawidłowa funkcja wątroby

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (4)

NCI - Center for Cancer Research

Bethesda, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, United States

University of Virginia Cancer Center

Charlottesville, United States

Trial contact

Site Public Contact

Robert J. Kreitman

PRINCIPAL_INVESTIGATOR

Seema A. Bhat

PRINCIPAL_INVESTIGATOR

Site Public Contact

Robert L. Redner

PRINCIPAL_INVESTIGATOR

Nathan L. Roberts

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/15/2026.

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