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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). 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.
Primary Outcome
MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/\> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle
Interventions
- DRUG Cyclophosphamide
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2006-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT00412243 record still lists
NCT00412243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT00412243 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00412243's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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