Actively Recruiting
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-15
86
Participants Needed
10
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older
- Histologically confirmed classical Hairy Cell Leukemia
- Presence of BRAF V600E mutation confirmed by PCR, NGS, or immunohistochemistry
- No prior therapy for Hairy Cell Leukemia
- Meet standard treatment initiation criteria: ANC 61.0, hemoglobin 610.0, or platelet count 6100,000
- ECOG performance status between 0 and 2
- Acceptable organ function: total bilirubin 61.5 x ULN, AST and ALT 62.5 x ULN, serum creatinine 61.5 x ULN
- ECG without significant ventricular arrhythmias or ischemia, QTc < 480 msec
- Agreement to use contraception during the study and specified periods after treatment for women of childbearing potential and men with female partners
- Negative pregnancy test within 7 days before starting treatment for women of childbearing potential
You will not qualify if you...
- Previous treatment for Hairy Cell Leukemia including purine analogs, vemurafenib, rituximab, obinutuzumab, or other investigational agents
- Known allergy to any study drugs
- Known long QT syndrome or uncorrectable electrolyte abnormalities
- Significant liver disease or current alcohol abuse
- Positive tests for hepatitis B or C, except for controlled occult HBV with monthly monitoring and prophylaxis
- Known infection with HIV or HTLV-1
- Active uncontrolled infection
- Live vaccination within 28 days before randomization
- Active malignancies requiring therapy except certain treated cancers in remission
- Malabsorption syndrome or conditions preventing oral medication
- Hairy Cell Leukemia variant (absence of CD25 expression)
- Pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
3
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
10
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
J
Jae Park, MD
CONTACT
M
Mark Geyer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here