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NCT03410875 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
A Phase 2 study of Leukemia and Hairy Cell Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 9
- Study locations
NCT03410875 is a Phase 2 study of Leukemia and Hairy Cell Leukemia that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 30 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (94% lower). The trial reports 9 study locations across 4 states.
The verdict
NCT03410875, a Phase 2 study of Leukemia and Hairy Cell Leukemia, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Vemurafenib
Study Locations (9)
New York
- Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering at Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Connecticut
- Yale University - New Haven
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03410875
The ClinicalTrials.gov registry entry for NCT03410875 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (94% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Obinutuzumab is the first listed.
NCT03410875 reports 9 study locations spanning 4 distinct geographic areas - top geographies include New York, New Jersey, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03410875 about?
NCT03410875 is a clinical study titled "A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia". 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....
What is the current status of trial NCT03410875?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-02-09. Estimated completion is 2027-01.
What conditions does trial NCT03410875 study?
This clinical trial studies the following conditions: Leukemia, Hairy Cell Leukemia, Leukemia, Hairy Cell.
What interventions are being tested in trial NCT03410875?
The interventions under investigation include: Obinutuzumab (DRUG), Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT03410875?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03410875 being conducted?
This trial has 9 study locations across Connecticut, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.