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NCT00778375 · ClinicalTrials.gov registry record · Phase 2
Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
NCT00778375: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00778375 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 122 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00778375, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.
Primary Outcome
Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, which
Interventions
- DRUG Decitabine
- DRUG Cytarabine
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2008-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT00778375 record still lists
NCT00778375 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Decitabine is the first listed.
NCT00778375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00778375 about?
NCT00778375 is a clinical study titled "Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.
What is the current status of trial NCT00778375?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2008-10. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00778375?
The interventions under investigation include: Decitabine (DRUG), Cytarabine (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT00778375?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00778375's enrollment target sits among peer trials
122 565th of 2000 higher than 1,434 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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