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NCT01289457 · ClinicalTrials.gov registry record · Phase 1
Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome
A Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 282
- Enrollment target
- 1
- Study location
NCT01289457: Completed Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT01289457 is a Phase 1 study of Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 282 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01289457, a Phase 1 study of Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 282 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied.
Primary Outcome
MTD is highest dose level in which \<2 patients of 6 develop first cycle dose limiting toxicities (DLT). Toxicity defined as any treatment-related grade 3 or greater non-hematological toxicities.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Clofarabine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2011-02-02 |
| Est. Completion | 2017-06-28 |
| Phase | Phase 1 |
What the finished NCT01289457 record still lists
NCT01289457 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.
NCT01289457 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01289457 about?
NCT01289457 is a clinical study titled "Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome". The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinat...
What is the current status of trial NCT01289457?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 282 participants. The study started on 2011-02-02. Estimated completion is 2017-06-28.
What conditions does trial NCT01289457 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT01289457?
The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT01289457?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01289457 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01289457's enrollment target sits among peer trials
282 30th of 233 higher than 204 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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