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NCT00372619 · ClinicalTrials.gov registry record · Phase 1
Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT00372619: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT00372619 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00372619, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
Primary Outcome
Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (\< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) \> 750/μL and platelet count \> 75,000/μL). Overall response for AML patients: (CR + CRp), defined as: CR - complete remission (attainment of an M1 bone marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recove
Interventions
- OTHER laboratory biomarker analysis
- DRUG clofarabine
- DRUG methotrexate
- DRUG cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2007-03 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT00372619 record still lists
NCT00372619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00372619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00372619 about?
NCT00372619 is a clinical study titled "Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia". RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I...
What is the current status of trial NCT00372619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2007-03. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00372619?
The interventions under investigation include: laboratory biomarker analysis (OTHER), clofarabine (DRUG), methotrexate (DRUG), cytarabine (DRUG).
Who is sponsoring clinical trial NCT00372619?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00372619's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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