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NCT04231851 · ClinicalTrials.gov registry record · Phase 2
CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia With Myelodysplasia-Related Changes and Acute Myelogenous Leukemia (AML) Due to Therapy, sponsored by University of California, Irvine.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT04231851: Active Phase 2 study of Acute Myeloid Leukemia With Myelodysplasia-Related Changes and Acute Myelogenous Leukemia (AML) Due to Therapy, sponsored by University of California, Irvine.
NCT04231851 is a Phase 2 study of Acute Myeloid Leukemia With Myelodysplasia-Related Changes and Acute Myelogenous Leukemia (AML) Due to Therapy that is active but no longer recruiting, run by University of California, Irvine. The registered enrollment target is 30 participants, below the 180-participant average among 4 other Acute Myeloid Leukemia With Myelodysplasia-Related Changes trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04231851, a Phase 2 study of Acute Myeloid Leukemia With Myelodysplasia-Related Changes and Acute Myelogenous Leukemia (AML) Due to Therapy, is active but no longer recruiting, sponsored by University of California, Irvine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase 2 single-arm, open-label clinical trial determining efficacy of CPX-351 in combination with Glasdegib in subjects with Acute Myelogenous Leukemia with myelodysplastic syndrome related changes or therapy-related acute myeloid leukemia.
Primary Outcome
This is defined as the percentage of subjects with event-free survival (EFS) at 6 months. EFS is defined as the number of months where patients are in a remission state.
Conditions Studied
Interventions
- DRUG CPX-351
- DRUG Glasdegib
Study Locations (4)
California
- University of California, Los Angeles - Los Angeles
- Chao Family Comprehensive Cancer Center, University of California, Irvine - Orange
- University of California, Davis - Sacramento
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04231851 still lists
NCT04231851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 180-participant average among 4 other Acute Myeloid Leukemia With Myelodysplasia-Related Changes trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia With Myelodysplasia-Related Changes appearing as the primary indexed condition, and to 2 interventions - of which CPX-351 is the first listed.
NCT04231851 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04231851 about?
NCT04231851 is a clinical study titled "CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia". This is a phase 2 single-arm, open-label clinical trial determining efficacy of CPX-351 in combination with Glasdegib in subjects with Acute Myelogenous Leukemia with myelodysplastic syndrome related changes or therapy-related acute myeloid leukemia.
What is the current status of trial NCT04231851?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2020-02-19. Estimated completion is 2027-06-30.
What conditions does trial NCT04231851 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Acute Myelogenous Leukemia (AML) Due to Therapy.
What interventions are being tested in trial NCT04231851?
The interventions under investigation include: CPX-351 (DRUG), Glasdegib (DRUG).
Who is sponsoring clinical trial NCT04231851?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04231851 being conducted?
This trial has 4 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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