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NCT00005945 · ClinicalTrials.gov registry record · Phase 3

Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia

A Phase 3 study of Leukemia, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 3
Development phase
3,054
Enrollment target
20
Study locations

NCT00005945: Completed Phase 3 study of Leukemia, sponsored by Children's Oncology Group.

NCT00005945 is a Phase 3 study of Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 3,054 participants, above the 474-participant average among 233 other Leukemia trials with a reported enrollment target (544% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005945, a Phase 3 study of Leukemia, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
3,054 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. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating childhood acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is comparing different combination chemotherapy regimens to see how well they work in treating children with acute lymphoblastic leukemia.

Primary Outcome

The primary outcome index used in examining the randomized treatment groups will be event free survival (EFS) from the time of randomization (i.e., end of Consolidation), where the life table events will consist of the first occurrence of leukemic relapse at any site, death, or occurrence of a second malignancy.

Conditions Studied

Leukemia

Interventions

  • DRUG cyclophosphamide
  • DRUG dexamethasone
  • DRUG doxorubicin hydrochloride
  • DRUG cytarabine
  • DRUG daunorubicin hydrochloride

Study Locations (20)

California

  • Southern California Permanente Medical Group - Downey
  • City of Hope Comprehensive Cancer Center - Duarte
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
  • Children's Hospital Los Angeles - Los Angeles
  • Samuel Oschin Comprehensive Cancer Institute 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 Medical Center - Orange
  • Children's Hospital of Orange County - Orange
  • Kaiser Permanente Medical Center - Sacramento - Sacramento
  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego - San Diego
  • UCSF Comprehensive Cancer Center - San Francisco
  • Santa Barbara Cottage Hospital - Santa Barbara
  • Kaiser Permanente Medical Center - Santa Clara - Santa Clara
  • General Robert Huyser Cancer Center at David Grant Medical Center - Travis Air Force Base

Colorado

  • Children's Hospital Cancer Center - Denver
  • Presbyterian - St. Luke's Medical Center - Denver

Arizona

  • Phoenix Children's Hospital - Phoenix

Connecticut

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center - Farmington

Trial Details

FieldValue
Enrollment Target 3,054 participants
Start Date 2000-06
Est. Completion 2008-06
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00005945 record still lists

NCT00005945 is an interventional study that assigns participants to a tested intervention. Its 3,054 participants enrollment target places it among the larger protocols in the corpus, above the 474-participant average among 233 other Leukemia trials with a reported enrollment target (544% higher).

The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00005945 names 20 study sites across 4 states, led by California, Colorado, Arizona.

Frequently Asked Questions

What is clinical trial NCT00005945 about?

NCT00005945 is a clinical study titled "Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating childhood acute lymphoblastic leukem...

What is the current status of trial NCT00005945?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,054 participants. The study started on 2000-06. Estimated completion is 2008-06.

What conditions does trial NCT00005945 study?

This clinical trial studies the following conditions: Leukemia.

What interventions are being tested in trial NCT00005945?

The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), doxorubicin hydrochloride (DRUG), cytarabine (DRUG), daunorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00005945?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00005945 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut. 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 NCT00005945's enrollment target sits among peer trials

3,054 4th of 233 higher than 230 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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Related registry views

Source: ClinicalTrials.gov NCT00005945, the US trial registry maintained by the National Library of Medicine. NCT00005945 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.