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NCT00067028 · ClinicalTrials.gov registry record · Phase 2
Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT00067028: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00067028 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00067028, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.
Primary Outcome
Response assessed by blood test or bone marrow aspirate following day 21 of induction and then every 2 weeks thereafter until remission or non-response. Complete remission (CR): Disappearance all clinical and/or radiologic evidence of disease; Neutrophil count \> 1.0 x10\^9/L and platelet count \>100x10\^9/L, and normal bone marrow differential (\< 5% blasts). Complete remission without platelet recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of \> 20
Interventions
- DRUG Clofarabine 40mg/m^2
- DRUG Idarubicin 10mg/m^2
- DRUG Ara-C 0.75 g/m^2
- DRUG Clofarabine 22.5mg/m^2
- DRUG Ara-C 1 g/m^2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2003-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT00067028 record still lists
NCT00067028 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which Clofarabine 40mg/m^2 is the first listed.
NCT00067028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00067028 about?
NCT00067028 is a clinical study titled "Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML)". The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.
What is the current status of trial NCT00067028?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2003-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00067028?
The interventions under investigation include: Clofarabine 40mg/m^2 (DRUG), Idarubicin 10mg/m^2 (DRUG), Ara-C 0.75 g/m^2 (DRUG), Clofarabine 22.5mg/m^2 (DRUG), Ara-C 1 g/m^2 (DRUG).
Who is sponsoring clinical trial NCT00067028?
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 NCT00067028's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 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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