Clinical trialNCT06965114RecruitingPhase 1/PHASE2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment84Hairy Cell LeukemiaRecurrent Hairy Cell LeukemiaRefractory Hairy Cell Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Seema A Bhat
Ohio State University Comprehensive Cancer Center LAO
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Nci - Center for Cancer Research
Bethesda, Maryland, United States
Robert J. Kreitman
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Seema A. Bhat
Recruiting
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Robert L. Redner
Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Nathan L. Roberts
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cladribine →Rituximab →Tovorafenib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 May 2026
Primary completion: 1 Mar 2030
Completion: 1 Mar 2030
Last update posted: 31 Jul 2026
Registered enrollment: 84
Registry id: NCT06965114

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.