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NCT00004228 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
A Phase 3 study of Lymphoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 393
- Enrollment target
- 20
- Study locations
NCT00004228: Completed Phase 3 study of Lymphoma, sponsored by Children's Oncology Group.
NCT00004228 is a Phase 3 study of Lymphoma that has completed, run by Children's Oncology Group. The registered enrollment target is 393 participants, below the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004228, a Phase 3 study of Lymphoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 393 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. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
Primary Outcome
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG dexamethasone
- DRUG cytarabine
- DRUG asparaginase
- 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
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital - Long Beach
- Childrens Hospital Los Angeles - Los Angeles
- Jonsson Comprehensive Cancer Center at UCLA - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital of Orange County - Orange
- Sutter Cancer Center - Sacramento
- University of California Davis Cancer Center - Sacramento
- Kaiser Permanente Medical Center - Oakland - Sacramento
- Children's Hospital and Health Center - San Diego - San Diego
- UCSF Comprehensive Cancer Center - San Francisco
- Stanford Comprehensive Cancer Center - Stanford - Stanford
Alabama
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock
Colorado
- Children's Hospital Cancer Center - Denver
Connecticut
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center - Farmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2000-06 |
| Est. Completion | 2015-03-31 |
| Phase | Phase 3 |
What the finished NCT00004228 record still lists
NCT00004228 is an interventional study that assigns participants to a tested intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, below the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00004228 names 20 study sites across 7 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00004228 about?
NCT00004228 is a clinical study titled "Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimen...
What is the current status of trial NCT00004228?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 393 participants. The study started on 2000-06. Estimated completion is 2015-03-31.
What conditions does trial NCT00004228 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT00004228?
The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), cytarabine (DRUG), asparaginase (DRUG), daunorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00004228?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00004228 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma
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 NCT00004228's enrollment target sits among peer trials
393 23rd of 299 higher than 277 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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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