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NCT03393611 · ClinicalTrials.gov registry record · Phase 1
CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome
A Phase 1 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03393611: Completed Phase 1 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Weill Medical College of Cornell University.
NCT03393611 is a Phase 1 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 14 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393611, a Phase 1 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory AML or myelodysplastic syndrome.
Primary Outcome
Evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG CPX-351
- DRUG Rabbit Anti-Human T-Lymphocyte Globulin
- BIOLOGICAL Haplo-Cord Stem Cell Transplantation
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-11-30 |
| Est. Completion | 2021-11-18 |
| Phase | Phase 1 |
What the finished NCT03393611 record still lists
NCT03393611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT03393611 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03393611 about?
NCT03393611 is a clinical study titled "CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome". This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory AML or myelodysplastic syndrome.
What is the current status of trial NCT03393611?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-11-30. Estimated completion is 2021-11-18.
What conditions does trial NCT03393611 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Previously Treated, Leukemia, Relapsed Adult Acute Myeloid.
What interventions are being tested in trial NCT03393611?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), CPX-351 (DRUG), Rabbit Anti-Human T-Lymphocyte Globulin (DRUG), Haplo-Cord Stem Cell Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03393611?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03393611 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 NCT03393611's enrollment target sits among peer trials
14 154th of 173 higher than 17 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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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