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NCT00004056 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00004056: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT00004056 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004056, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by melphalan and peripheral stem cell transplantation in treating children who have newly diagnosed acute myeloid leukemia that has not been treated previously.
Primary Outcome
To determine the feasibility and toxicity of an intensive regimen that uses timed-sequential therapy as a strategy for both remission induction and consolidation of newly diagnosed children with AML.
Interventions
- DRUG melphalan
- BIOLOGICAL filgrastim
- DRUG cytarabine
- DRUG asparaginase
- DRUG daunorubicin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 1999-10 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
What the finished NCT00004056 record still lists
NCT00004056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 5 interventions - of which melphalan is the first listed.
NCT00004056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004056 about?
NCT00004056 is a clinical study titled "Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of...
What is the current status of trial NCT00004056?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 1999-10. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00004056?
The interventions under investigation include: melphalan (DRUG), filgrastim (BIOLOGICAL), cytarabine (DRUG), asparaginase (DRUG), daunorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00004056?
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 NCT00004056's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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