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NCT00003593 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
A Phase 3 study of Leukemia and Myelodysplastic Syndromes, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 254
- Enrollment target
- 20
- Study locations
NCT00003593: Completed Phase 3 study of Leukemia and Myelodysplastic Syndromes, sponsored by Children's Oncology Group.
NCT00003593 is a Phase 3 study of Leukemia and Myelodysplastic Syndromes that has completed, run by Children's Oncology Group. The registered enrollment target is 254 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003593, a Phase 3 study of Leukemia and Myelodysplastic Syndromes, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 254 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
Conditions Studied
Interventions
- DRUG methotrexate
- DRUG cytarabine
- DRUG asparaginase
- DRUG daunorubicin hydrochloride
- DRUG therapeutic hydrocortisone
Study Locations (20)
California
- Southern California Permanente Medical Group - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Rebecca and John Moores UCSD Cancer Center - La Jolla
- Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center - Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital and Research Center at Oakland - Oakland
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center - Orange
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital at Stanford University Medical Center - Palo Alto
- Sutter Cancer Center - Sacramento
- University of California Davis Cancer Center - Sacramento
Alabama
- University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham
- University of South Alabama Cancer Research Institute - Mobile
Arizona
- Phoenix Children's Hospital - Phoenix
- Arizona Cancer Center at University of Arizona Health Sciences Center - Tucson
Arkansas
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 1999-06 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT00003593 record still lists
NCT00003593 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (48% lower).
The record links to 3 conditions, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which methotrexate is the first listed.
NCT00003593 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00003593 about?
NCT00003593 is a clinical study titled "Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome...
What is the current status of trial NCT00003593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 1999-06. Estimated completion is 2012-04.
What conditions does trial NCT00003593 study?
This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms.
What interventions are being tested in trial NCT00003593?
The interventions under investigation include: methotrexate (DRUG), cytarabine (DRUG), asparaginase (DRUG), daunorubicin hydrochloride (DRUG), therapeutic hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT00003593?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003593 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00003593's enrollment target sits among peer trials
254 35th of 233 higher than 199 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.
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