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Phase III Study Treatment of CLL B and C

NCT00535912 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2007-11-01

No results posted yet for this study

Summary

GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in case of response. Experimental arm consisted of high dose therapy with autologous CD34+ purified progenitor cell support, used as consolidation of Complete Remission or Very Good Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses of fludarabine in case of insufficient response.

Conditions

  • Leukemia, Lymphocytic, Chronic

Interventions

PROCEDURE

Stem cells autograft

Treatment by Intensive Chemotherapy and autograft

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Annie BRION, RN · French Innovative Leukemia Organisation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Completion
2006-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00535912 on ClinicalTrials.gov