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NCT00831766 · ClinicalTrials.gov registry record · Phase 1
Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 2
- Study locations
NCT00831766: Completed Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00831766 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 51 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (56% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00831766, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to: * Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine * See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine * See how long people respond to this combination therapy * See how long people live after being treated with this combination of drugs
Primary Outcome
For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Lenalidomide (Revlimid®)
Study Locations (2)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Ohio
- Cleveland Clinic - Taussig Cancer Institute - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2009-06-25 |
| Est. Completion | 2020-11-16 |
| Phase | Phase 1 |
What the finished NCT00831766 record still lists
NCT00831766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Cytarabine is the first listed.
NCT00831766 reports a single indexed study location in Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT00831766 about?
NCT00831766 is a clinical study titled "Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)". The purpose of this study is to: * Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine * See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine * See how long people respond to this combination therapy * See how lon...
What is the current status of trial NCT00831766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2009-06-25. Estimated completion is 2020-11-16.
What conditions does trial NCT00831766 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT00831766?
The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Lenalidomide (Revlimid®) (DRUG).
Who is sponsoring clinical trial NCT00831766?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00831766 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00831766's enrollment target sits among peer trials
51 141st of 306 higher than 165 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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