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 (Sep 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: BRAF v600e
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: purine analog
Have had previous treatment for HCL, including purine analogs
Cannot have received: BRAF inhibitor (vemurafenib)
Have had previous treatment for HCL, including ... vemurafenib
Cannot have received: anti-CD20 therapy (rituximab, obinutuzumab)
Have had previous treatment for HCL, including ... rituximab, obinutuzumab
Cannot have received: investigational agent
Have had previous treatment for HCL, including ... other investigational agents
Lab requirements
Blood counts
ANC 1.0, Hgb 10.0, PLT 100K
Kidney function
Serum creatinine 1.5x ULN
Liver function
Total bilirubin 1.5x ULN (Gilbert's syndrome: direct bilirubin 3x ULN); AST/ALT 2.5x ULN
Cardiac function
ECG without evidence of clinically significant ventricular arrhythmias or ischemia; QTc (Bazett's formula) < 480 msec
Acceptable pre-study organ function during screening as defined as: Total bilirubin 1.5x ULN (Gilbert's syndrome: direct bilirubin 3x ULN); AST/ALT 2.5x ULN; Serum creatinine 1.5x ULN; ANC 1.0, Hgb 10.0, PLT 100K; ECG without evidence of clinically significant ventricular arrhythmias or ischemia; QTc (Bazett's formula) < 480 msec
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 →Frequently asked questions
Is NCT06561360 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require BRAF?
Yes, BRAF v600e is a required biomarker for enrollment.
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 qualifyRelated pages