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NCT00983528 · ClinicalTrials.gov registry record · Phase 1
Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase 1 study, sponsored by University of California, San Diego.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00983528: Clinical Trial Phase 1 study, sponsored by University of California, San Diego.
NCT00983528 is a Phase 1 study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983528, a Phase 1 study, was terminated before completion, sponsored by University of California, San Diego.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Clofarabine is approved by the FDA for the treatment of pediatric patients (1 to 21 years of age) with relapsed or refractory ALL. Alemtuzumab is approved by the FDA for treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients over the age of 18. These drugs have been used to treat patients with leukemia in other research studies like this one. Both drugs have individually been administered to adult patients with ALL with acceptable toxicity profiles. This study will evaluate the combination of clofarabine and alemtuzumab when administered to adult patients with relapsed or refractory ALL. Primary objectives of the study is to determine the maximum tolerated dose of clofarabine when administered with alemtuzumab, evaluate the safety of the combination, and assess for activity of the combination by evaluating response rate, effect on ALL progenitor cell population, and patients who are able to bridge to transplant.
Interventions
- DRUG Clofarabine
- BIOLOGICAL Alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
Why NCT00983528 stopped before completion
NCT00983528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Clofarabine is the first listed.
NCT00983528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00983528 about?
NCT00983528 is a clinical study titled "Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia". Clofarabine is approved by the FDA for the treatment of pediatric patients (1 to 21 years of age) with relapsed or refractory ALL. Alemtuzumab is approved by the FDA for treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients over the age of 18. These drugs have been used to treat patie...
What is the current status of trial NCT00983528?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2009-09. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00983528?
The interventions under investigation include: Clofarabine (DRUG), Alemtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00983528?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00983528's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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