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NCT00875693 · ClinicalTrials.gov registry record · Phase 1
A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning (RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT) for Primary Refractory and Relapsed Acute Myelogenous Leukemia (AML)
A Phase 1 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT00875693: Completed Phase 1 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, sponsored by Weill Medical College of Cornell University.
NCT00875693 is a Phase 1 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 47 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00875693, a Phase 1 study of Myelodysplastic Syndrome and Acute Myelogenous Leukemia, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for CPX-351 followed by a reduced intensity conditioning regimen and incorporates a dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination of the MTD, the investigator reserves the option to enroll up to 10 additional subjects in an expanded safety cohort(s) at the MTD. Refractory and relapsed AML patients who meet standard institutional criteria to undergo sequential induction/reduced intensity conditioning allogeneic transplants will be offered a transplant from a related or unrelated donor (full match or 1 antigen mismatch). Cord blood transplants will not be used in this study.
Conditions Studied
Interventions
- DRUG CPX-351
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2009-06-02 |
| Est. Completion | 2017-12-27 |
| Phase | Phase 1 |
What the finished NCT00875693 record still lists
NCT00875693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which CPX-351 is the first listed.
NCT00875693 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00875693 about?
NCT00875693 is a clinical study titled "A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning (RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT) for Primary Refractory and Relapsed Acute Myelogenous Leukemia (AML)". This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for CPX-351 followed by a reduced intensity conditioning regimen and incorporates a dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination of the MTD, the investigator reserv...
What is the current status of trial NCT00875693?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2009-06-02. Estimated completion is 2017-12-27.
What conditions does trial NCT00875693 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT00875693?
The interventions under investigation include: CPX-351 (DRUG).
Who is sponsoring clinical trial NCT00875693?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00875693 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 NCT00875693's enrollment target sits among peer trials
47 73rd of 134 higher than 62 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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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