OncoMatch/Clinical Trials/NCT06965114
Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
Is NCT06965114 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Rituximab and Cladribine for hairy cell leukemia.
Treatment: Cladribine · Rituximab · Tovorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hairy Cell Leukemia
Biomarker criteria
Required: BRAF v600e
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: purine nucleoside analog-containing regimen (fludarabine, pentostatin, cladribine) — PHASE 1 ONLY
PHASE 1 ONLY: Prior therapy with at least one purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine) unless contraindicated.
Cannot have received: HCL-directed treatment
PHASE 2 ONLY: No prior HCL-directed treatment for front-line cohort. The design of this cohort is such that the patients will need to be treatment naïve
Lab requirements
Blood counts
Absolute neutrophil count < 1,000/mcL; Platelets < 100,000/mcL; Hemoglobin < 10 g/dL (for treatment indication); Exclusion: Platelets < 50,000/mcL
Kidney function
Creatinine clearance (ClCr) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST/ALT ≤ 3 x institutional ULN (unless related to Gilbert's disease or HCL; patients with documented Gilbert's disease may be enrolled with sponsor approval provided total bilirubin is ≤ 2.0 x ULN)
Cardiac function
ECG without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of < 480 msec
Total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST/ALT ≤ 3 x institutional ULN (unless related to Gilbert's disease or HCL; patients with documented Gilbert's disease may be enrolled with sponsor approval provided total bilirubin is ≤ 2.0 x ULN); Creatinine clearance (ClCr) ≥ 30 mL/min; ECG without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of < 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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