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NCT00003735 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
A Phase 2 study of Leukemia, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 20
- Study locations
NCT00003735: Completed Phase 2 study of Leukemia, sponsored by Children's Oncology Group.
NCT00003735 is a Phase 2 study of Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 11 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003735, a Phase 2 study of Leukemia, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of topotecan in treating children who have relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous leukemia.
Primary Outcome
For each stratum, this trial will determine topotecan to have insufficient activity for further investigation with probability 0.10 if the true response rate is 20%. For each stratum, this trial will determine topotecan to be of sufficient activity to warrant further investigation with probability 0.12 if the true response rate is 5%. Any patient who receives at least 21 days of therapy will be considered evaluable for response.
Conditions Studied
Interventions
- DRUG topotecan hydrochloride
Study Locations (20)
California
- Long Beach Memorial Medical Center - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA - Los Angeles
- Children's Hospital of Orange County - Orange
- UCSF Cancer Center and Cancer Research Institute - San Francisco
New York
- NYU School of Medicine's Kaplan Comprehensive Cancer Center - New York
- Memorial Sloan-Kettering Cancer Center - New York
- Herbert Irving Comprehensive Cancer Center - New York
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
- CCOP - Kalamazoo - Kalamazoo
New Jersey
- Cancer Institute of New Jersey - New Brunswick
- St. Joseph's Hospital and Medical Center - Paterson
Colorado
- Children's Hospital of Denver - Denver
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- University of Chicago Cancer Research Center - Chicago
Indiana
- Indiana University Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 1998-12 |
| Est. Completion | 2006-09 |
| Phase | Phase 2 |
What the finished NCT00003735 record still lists
NCT00003735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which topotecan hydrochloride is the first listed.
NCT00003735 names 20 study sites across 12 states, led by California, New York, Michigan.
Frequently Asked Questions
What is clinical trial NCT00003735 about?
NCT00003735 is a clinical study titled "Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of topotecan in treating children who have relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous ...
What is the current status of trial NCT00003735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 1998-12. Estimated completion is 2006-09.
What conditions does trial NCT00003735 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT00003735?
The interventions under investigation include: topotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00003735?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003735 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00003735's enrollment target sits among peer trials
11 214th of 233 higher than 18 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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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