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NCT01794702 · ClinicalTrials.gov registry record · Phase 1
Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
A Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT01794702: Completed Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT01794702 is a Phase 1 study of Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 65 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01794702, a Phase 1 study of Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia. The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied. Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
Primary Outcome
Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Clofarabine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-02-20 |
| Est. Completion | 2018-01-11 |
| Phase | Phase 1 |
What the finished NCT01794702 record still lists
NCT01794702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Decitabine is the first listed.
NCT01794702 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01794702 about?
NCT01794702 is a clinical study titled "Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia". The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia. The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabin...
What is the current status of trial NCT01794702?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2013-02-20. Estimated completion is 2018-01-11.
What conditions does trial NCT01794702 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT01794702?
The interventions under investigation include: Decitabine (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT01794702?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01794702 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
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Where NCT01794702's enrollment target sits among peer trials
65 93rd of 233 higher than 140 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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