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NCT00088218 · ClinicalTrials.gov registry record · Phase 2
Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT00088218: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00088218 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088218, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.
Primary Outcome
Participant responses are categorized as 'Complete Remission,' Complete Remission, No Platelet Recovery,' 'No Response.' Complete Remission: Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 109/L and platelet count \> 100 x 109/L, and normal bone marrow differential (\< 5% blasts); Complete Remission, No Platelet Recovery: Peripheral blood and bone marrow results as for CR, but with platelet counts of \< 100 x 109/L. Blood draws once a week until r
Interventions
- DRUG Clofarabine
- DRUG Ara-C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2004-07 |
| Est. Completion | 2008-02 |
| Phase | Phase 2 |
What the finished NCT00088218 record still lists
NCT00088218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Clofarabine is the first listed.
NCT00088218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00088218 about?
NCT00088218 is a clinical study titled "Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).". The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments wil...
What is the current status of trial NCT00088218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2004-07. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00088218?
The interventions under investigation include: Clofarabine (DRUG), Ara-C (DRUG).
Who is sponsoring clinical trial NCT00088218?
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 NCT00088218's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 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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