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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 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.

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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

Conditions Studied

B-cell Lymphoma

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

FieldValue
Enrollment Target 848 participants
Start Date 1996-05
Est. Completion 2011-05
Phase Phase 3

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00162656

The ClinicalTrials.gov registry entry for NCT00162656 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 848 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 68-participant average among 38 other B-cell Lymphoma trials with a reported enrollment target (1147% higher). The listed sponsor is Gustave Roussy, Cancer Campus, Grand Paris, which has 3 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.