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NCT03335267 · ClinicalTrials.gov registry record · Phase 2
Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia
A Phase 2 study of Leukemia, Myeloid, Acute, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03335267: Completed Phase 2 study of Leukemia, Myeloid, Acute, sponsored by Weill Medical College of Cornell University.
NCT03335267 is a Phase 2 study of Leukemia, Myeloid, Acute that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 30 participants, below the 115-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03335267, a Phase 2 study of Leukemia, Myeloid, Acute, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label study to assess the suitability of CPX-351 as first intensive therapy in elderly (age ≥60 years) patients with AML. Patients may have received prior AML treatment with non-intensive regimens, e.g. hypomethylating agents, low dose Ara C or lenolidomide, but may not have received intensive AML treatment with anthracyclines and/or cytarabine prior to enrollment on this trial. The outcome of elderly patients following intensive treatment with CPX-351 will be measured by clinical endpoints for efficacy and safety and by biological/functional response.
Primary Outcome
Overall survival is measured from the date of registration to death from any cause. Patients not known to have died will be censored on the date they were last known to be alive. Patients were followed for 2.5 years.
Conditions Studied
Interventions
- DRUG CPX-351
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2020-05-29 |
| Phase | Phase 2 |
What the finished NCT03335267 record still lists
NCT03335267 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 115-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 1 intervention - of which CPX-351 is the first listed.
NCT03335267 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03335267 about?
NCT03335267 is a clinical study titled "Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia". This is an open label study to assess the suitability of CPX-351 as first intensive therapy in elderly (age ≥60 years) patients with AML. Patients may have received prior AML treatment with non-intensive regimens, e.g. hypomethylating agents, low dose Ara C or lenolidomide, but may not have received...
What is the current status of trial NCT03335267?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-10-19. Estimated completion is 2020-05-29.
What conditions does trial NCT03335267 study?
This clinical trial studies the following conditions: Leukemia, Myeloid, Acute.
What interventions are being tested in trial NCT03335267?
The interventions under investigation include: CPX-351 (DRUG).
Who is sponsoring clinical trial NCT03335267?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03335267 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03335267's enrollment target sits among peer trials
30 24th of 30 higher than 6 of 30 other Leukemia, Myeloid, Acute trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia, Myeloid, Acute trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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