Vemurafenib + Obinutuzumab for Hairy Cell Leukemia

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byJae Park, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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

My organs are functioning well according to recent tests.

Patients who meet the standard treatment initiation criteria, as defined by ANC </=1.0, Hgb </=10.0 or PLT </=100K

Total bilirubin </= 1.5 times the upper limit of normal (ULN)

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Exclusion Criteria

I have been diagnosed with HIV or HTLV-1.

You have severe allergies to any of the study drugs.

Patients with uncorrectable electrolyte abnormalities with potassium (K) >ULN (upper limit of normal).

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Treatment Details

Interventions

Obinutuzumab (Monoclonal Antibodies)
Vemurafenib (BRAF Inhibitor)

Trial OverviewThe trial is testing an oral drug called Vemurafenib combined with Obinutuzumab infusions against Hairy Cell Leukemia. Initially, 9 patients will receive this combination to see if it's effective; if successful, another 19 will join. The treatment spans over four cycles (16 weeks), followed by bone marrow tests for response evaluation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Untreated Hairy Cell LeukemiaExperimental Treatment2 Interventions

Participants with HCL with no prior treatment for the disease