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NCT00061945 · ClinicalTrials.gov registry record · Phase 1
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 302
- Enrollment target
NCT00061945: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00061945 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 302 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (403% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00061945, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 302 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.
Primary Outcome
The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed
Interventions
- DRUG cyclophosphamide
- DRUG dexamethasone
- DRUG vincristine sulfate
- DRUG allopurinol
- DRUG daunorubicin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2003-06 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00061945 record still lists
NCT00061945 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (403% higher).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00061945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00061945 about?
NCT00061945 is a clinical study titled "Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia". This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in differen...
What is the current status of trial NCT00061945?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 302 participants. The study started on 2003-06. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00061945?
The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), vincristine sulfate (DRUG), allopurinol (DRUG), daunorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00061945?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00061945's enrollment target sits among peer trials
302 124th of 2000 higher than 1,877 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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