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NCT00499889 · ClinicalTrials.gov registry record · Phase 2
Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT00499889: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00499889 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00499889, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
Primary Objective: To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogenous Leukemia (CML) not in blastic transformation. Secondary Objective: Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib mesylate therapy, as well as engraftment, toxicity, disease free survival and survival, effect of busulfan pharmacokinetics on study outcome.
Primary Outcome
Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).
Interventions
- DRUG Busulfan
- DRUG Tacrolimus
- DRUG Fludarabine (Fludara)
- DRUG Imatinib Mesylate
- DRUG Antithymocyte Globulin (ATG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2003-02 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
Why NCT00499889 stopped before completion
NCT00499889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Busulfan is the first listed.
NCT00499889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00499889 about?
NCT00499889 is a clinical study titled "Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients". Primary Objective: To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogeno...
What is the current status of trial NCT00499889?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2003-02. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00499889?
The interventions under investigation include: Busulfan (DRUG), Tacrolimus (DRUG), Fludarabine (Fludara) (DRUG), Imatinib Mesylate (DRUG), Antithymocyte Globulin (ATG) (DRUG).
Who is sponsoring clinical trial NCT00499889?
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 NCT00499889's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 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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