Vemurafenib + Obinutuzumab for Hairy Cell Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medications that could interact with vemurafenib or obinutuzumab, you may need to discuss this with the trial team.
What data supports the effectiveness of the drug Vemurafenib for treating Hairy Cell Leukemia?
Is the combination of Vemurafenib and Obinutuzumab safe for humans?
Obinutuzumab, used in various treatments, has shown a generally manageable safety profile in humans, with common side effects including mild to moderate infusion-related reactions and neutropenia (low white blood cell count). Serious side effects can occur, but they are typically manageable with proper medical care.678910
How is the drug combination of Vemurafenib and Obinutuzumab unique for treating hairy cell leukemia?
The combination of Vemurafenib and Obinutuzumab is unique for treating hairy cell leukemia because it targets the BRAF V600E mutation with Vemurafenib, an oral BRAF inhibitor, and combines it with Obinutuzumab, a monoclonal antibody that enhances the immune system's ability to attack cancer cells. This dual approach may offer a novel treatment option for patients who have relapsed or are refractory to standard therapies.15111213
What is the purpose of this trial?
This is a multi-center, open label, single arm, phase II trial of the oral BRAF inhibitor, vemurafenib, plus obinutuzumab in patients with previously untreated HCL. A Simon mini-max two-stage design will be employed to assess the efficacy of the combination treatment of vemurafenib and obinutuzumab. In the first stage of the protocol, 9 patients will be treated. If fewer than 6 CRs are seen among the first 9 patients, the study will be closed for lack of efficacy. If at least 7 patients respond to the treatment, then an additional 19 patients will be accrued to the second stage, for a total of 28 patients.Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks. Obinutuzumab infusions will be administered at 1000mg per day on days 1, 8 and 15 during the cycle 2 and 1000mg per day every 4 weeks during the cycle 3 and 4 of treatment. After the completion of the treatment (i.e. after 4 cycles), a bone marrow aspirate and biopsy will be performed for assessment of response and evaluation of minimal residual disease (MRD). In case of certain defined toxicities, dose reductions of vemurafenib by 50% (480mg b.i.d.) or interruptions of up to 15 days are permitted. If additional dose reduction is required, vemurafenib may be reduced to 240mg oral b.i.d.
Research Team
Jae Park, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with previously untreated classical Hairy Cell Leukemia who meet specific blood count criteria and are in good physical condition. They must have normal organ function, agree to use contraception, and not be pregnant. Excluded are those with hepatitis B or C, HIV, other cancers needing treatment that could interact with the trial drugs, uncontrolled infections, or a history of liver disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vemurafenib and obinutuzumab over 4 cycles of 4 weeks each
Follow-up
Participants are monitored for safety and effectiveness after treatment, including bone marrow aspirate and biopsy
Treatment Details
Interventions
- Obinutuzumab
- Vemurafenib
Obinutuzumab is already approved in United States, European Union for the following indications:
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Dana-Farber Cancer Institute
Collaborator
Yale University
Collaborator