OncoMatch/Clinical Trials/NCT06561360
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
Is NCT06561360 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Vemurafenib and Obinutuzumab for hairy cell leukemia.
Treatment: Vemurafenib · Obinutuzumab · Cladribine · Rituximab — The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.
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
Cannot have received: any prior therapy for HCL (purine analogs, vemurafenib, rituximab, obinutuzumab, other investigational agents)
Exception: Previous treatment with transfusions and other supportive care such as G-CSF and erythropoietin are allowed.
Have had previous treatment for HCL, including purine analogs, vemurafenib, rituximab, obinutuzumab, and other investigational agents. Previous treatment with transfusions and other supportive care such as G-CSF and erythropoietin are allowed.
Lab requirements
Blood counts
ANC 1.0, Hgb 10.0 or PLT 100K (treatment initiation criteria)
Kidney function
Serum creatinine 1.5x ULN
Liver function
Total bilirubin 1.5x ULN; AST and ALT 2.5x ULN
Cardiac function
ECG without evidence of clinically significant ventricular arrhythmias or ischemia; QTc (Bazett's) < 480 msec
Acceptable pre-study organ function during screening as defined as: Total bilirubin 1.5x ULN; AST and ALT 2.5x ULN; Serum creatinine 1.5x ULN; 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; Patients who meet the standard treatment initiation criteria, as defined by ANC 1.0, Hgb 10.0 or PLT 100K
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
- Mayo Clinic Cancer Center · Rochester, Minnesota
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify