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NCT04409639 · ClinicalTrials.gov registry record · Phase 2
Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations
A Phase 2 study of Chronic Myelomonocytic Leukemia (CMML), sponsored by University of Utah.
- Active
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 3
- Study locations
NCT04409639: Active Phase 2 study of Chronic Myelomonocytic Leukemia (CMML), sponsored by University of Utah.
NCT04409639 is a Phase 2 study of Chronic Myelomonocytic Leukemia (CMML) that is active but no longer recruiting, run by University of Utah. The registered enrollment target is 29 participants, below the 161-participant average among 6 other Chronic Myelomonocytic Leukemia (CMML) trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04409639, a Phase 2 study of Chronic Myelomonocytic Leukemia (CMML), is active but no longer recruiting, sponsored by University of Utah.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is an open-label, nonrandomized phase 2 trial to assess the efficacy of cobimetinib in RAS pathway activated CMML. All eligible patients will be treated daily with cobimetinib in 28-day cycles. Cobimetinib will be administered for three weeks followed by a one week break prior to the start of the following cycle. Patients will remain on study therapy until treatment discontinuation criteria is met.
Primary Outcome
To assess the efficacy of cobimetinib in patients with newly diagnosed and HMA- refractory chronic myelomonocytic leukemia (CMML). Overall response rate (ORR) is defined as the proportion of patients achieving complete remission, complete cytogenetic remission, partial remission, marrow response, and clinical benefit according to the 2015 MDS/MPN-IWG criteria. This was assessed from the dose of study medication to the decision to end treatment, up to 20 months.
Conditions Studied
Interventions
- DRUG Cobimetinib
Study Locations (3)
Oregon
- Oregon Health and Science University - Portland
Utah
- Huntsman Cancer Institute at University of Utah - Salt Lake City
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What the registry record for NCT04409639 still lists
NCT04409639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 161-participant average among 6 other Chronic Myelomonocytic Leukemia (CMML) trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Chronic Myelomonocytic Leukemia (CMML) appearing as the primary indexed condition, and to 1 intervention - of which Cobimetinib is the first listed.
NCT04409639 reports a single indexed study location in Oregon, Utah, Washington.
Frequently Asked Questions
What is clinical trial NCT04409639 about?
NCT04409639 is a clinical study titled "Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations". This is an open-label, nonrandomized phase 2 trial to assess the efficacy of cobimetinib in RAS pathway activated CMML. All eligible patients will be treated daily with cobimetinib in 28-day cycles. Cobimetinib will be administered for three weeks followed by a one week break prior to the start of ...
What is the current status of trial NCT04409639?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2021-01-12. Estimated completion is 2026-08.
What conditions does trial NCT04409639 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia (CMML).
What interventions are being tested in trial NCT04409639?
The interventions under investigation include: Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT04409639?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04409639 being conducted?
This trial has 3 study locations across Oregon, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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