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NCT00412243 · ClinicalTrials.gov registry record · Phase 1
Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT00412243: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00412243 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412243, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of the drugs clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or refractory ALL. The safety of the combination treatment will also be studied. Objectives: Phase I: 1. To establish toxicities and safety of the proposed combination 2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination to proceed with the phase II part of the study Phase II: 3. To establish the efficacy (complete and overall response) of the proposed combination. 4. To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination.
Interventions
- DRUG Cyclophosphamide
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2006-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00412243
The ClinicalTrials.gov registry entry for NCT00412243 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 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 2 interventions - of which Cyclophosphamide is the first listed.
NCT00412243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00412243 about?
NCT00412243 is a clinical study titled "Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients". The goal of this clinical research study is to find the highest tolerable dose of the drugs clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or refractory ALL. The safety of the combination treatment will also be studied. Objectives: Phase I: 1. To establis...
What is the current status of trial NCT00412243?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2006-03. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00412243?
The interventions under investigation include: Cyclophosphamide (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT00412243?
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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