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NCT00162656 · ClinicalTrials.gov registry record · Phase 3
Treatment of Mature B-cell Lymphoma/Leukaemia
A Phase 3 study of B-cell Lymphoma, sponsored by Gustave Roussy, Cancer Campus, Grand Paris.
- Completed
- Registry status
- Phase 3
- Development phase
- 848
- Enrollment target
- 3
- Study locations
NCT00162656: Completed Phase 3 study of B-cell Lymphoma, sponsored by Gustave Roussy, Cancer Campus, Grand Paris.
NCT00162656 is a Phase 3 study of B-cell Lymphoma that has completed, run by Gustave Roussy, Cancer Campus, Grand Paris. The registered enrollment target is 848 participants, above the 68-participant average among 38 other B-cell Lymphoma trials with a reported enrollment target (1147% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00162656, a Phase 3 study of B-cell Lymphoma, has completed, sponsored by Gustave Roussy, Cancer Campus, Grand Paris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 848 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment
Primary Outcome
Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)
Conditions Studied
Interventions
- DRUG half cyclophosphamide
- DRUG without COPADM3
- DRUG mini CYVE, without 3 maintenance courses
- DRUG LMB B
- DRUG LMB C
Study Locations (3)
Other
- Institut Gustave Roussy - Villejuif
- Sheffield Children's Hospital - Sheffield
New York
- Morgan Stanley Childrens Hospital of New York Presbyterian - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 848 participants |
| Start Date | 1996-05 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00162656 record still lists
NCT00162656 is an interventional study that assigns participants to a tested intervention. The registered 848 participants enrollment target is mid-sized for trials with a published cap, above the 68-participant average among 38 other B-cell Lymphoma trials with a reported enrollment target (1147% higher).
The record links to 1 condition, with B-cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which half cyclophosphamide is the first listed.
NCT00162656 reports a single indexed study location in Other, New York.
Frequently Asked Questions
What is clinical trial NCT00162656 about?
NCT00162656 is a clinical study titled "Treatment of Mature B-cell Lymphoma/Leukaemia". This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of prog...
What is the current status of trial NCT00162656?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 848 participants. The study started on 1996-05. Estimated completion is 2011-05.
What conditions does trial NCT00162656 study?
This clinical trial studies the following conditions: B-cell Lymphoma.
What interventions are being tested in trial NCT00162656?
The interventions under investigation include: half cyclophosphamide (DRUG), without COPADM3 (DRUG), mini CYVE, without 3 maintenance courses (DRUG), LMB B (DRUG), LMB C (DRUG).
Who is sponsoring clinical trial NCT00162656?
This trial is sponsored by Gustave Roussy, Cancer Campus, Grand Paris, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00162656 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00162656's enrollment target sits among peer trials
848 1st of 38 higher than 38 of 38 other B-cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B-cell 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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