A Study of Vemurafenib and Obinutuzumab for Hairy Cell Leukemia
This study is for people with Hairy Cell Leukemia (HCL) that has a specific genetic change called BRAF V600E. Researchers are comparing two treatment approaches: vemurafenib and obinutuzumab (non-chemotherapy drugs) versus cladribine and rituximab (chemotherapy drugs). The main goal is to see which treatment causes fewer or milder side effects. They also want to find out which approach is better at getting rid of cancer cells. You can join if you are 18 or older and have confirmed HCL with the BRAF V600E mutation. The study plans to enroll 86 participants, but its current status is unclear.
- Study design
- This study is comparing two different drug combinations for Hairy Cell Leukemia. It plans to enroll 86 participants.
- What's involved
- Vemurafenib is taken by mouth twice daily for 4 cycles. Obinutuzumab is given with vemurafenib starting in cycle 2. Cladribine and rituximab are given intravenously (IV) on days 1-5.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track side effects for up to 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06561360
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~86 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:VemurafenibObinutuzumabCladribineRituximab
At a glance
Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
incidences of ≥ grade 3 treatment-related toxicities
Measured over within 6 months of treatment
Conditions
Where it's being run
10 sites across 5 statesNew York4
New Jersey3
Massachusetts1
Minnesota1
Ohio1
Study leadership
- Jae Park, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must be ≥ 18 years of age
Histologically confirmed classical HCL by the enrolling institution
Presence of BRAF V600E mutation as confirmed by PCR, NGS or immunohistochemistry. If patient is known to have negative BRAF mutation, repeat testing is advisable as well as discussion with the main study principal investigator.
Has not received any prior therapy for the disease
Patients who meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K
ECOG performance status of 0 - 2
Acceptable pre-study organ function during screening as defined as:
Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except in patients with known Gilbert's syndrome who may be enrolled if direct bilirubin ≤ 3 x ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN; and
Serum creatinine ≤ 1.5x ULN
Electrocardiogram (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
For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib and cladribine, and 18 months after discontinuation of rituximab and obinutuzumab
For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of vemurafenib
Negative serum pregnancy test within 7 days of commencement of treatment in women of childbearing potential
Exclusion
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.
Known hypersensitivity to any of the study drugs.
Patients with known long QT syndrome or uncorrectable electrolyte abnormalities
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody
Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)
Active uncontrolled infection, e.g. persistent bacteremia, supplemental oxygen or pressor supports, etc.
Live vaccination within 28 days of randomization
Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I/II cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years
Malabsorption syndrome or other condition that precludes enteral route of administration
Patients with HCL variant (as defined by absence of expression of CD25)
Pregnant or lactating, or intending to become pregnant during the study
What this trial measures
- incidences of ≥ grade 3 treatment-related toxicitieswithin 6 months of treatment
per CTCAE v5.0 within first 6 months from the start of the treatment to account delayed toxicities of the treatments