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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00499889
The ClinicalTrials.gov registry entry for NCT00499889 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Busulfan is the first listed.
NCT00499889 reports 0 study locations.
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.
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