CompletedPhase 3

Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia

France241 participantsStarted 2001-04

Plain-language summary

Phase III trial evaluating the role of autologous stem cell transplantation in previously untreated patients under 65 years with stage B and C B-cell chronic lymphocytic leukemia. Endpoints of the trial : * major : progression free survival at 3 years * secondary : overall survival, tolerance, prognostic factors according to baseline clinical stage and biological characteristics (IgHv mutational status, expression of ZAP70 and CD38, cytogenetics).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients with stage B \& C CLL, 18- 65 years. * previously untreated * given written informed consent Exclusion Criteria: * Childbearing women * OMS Performance status \> 2 * Binet stage A * Autoimmune hemolytic anemia * Active or previous (\< 5 years) malignant disease, except cutaneous cell carcinoma. * Previous CLL treatment * HIV seropositivity * Abnormal renal or liver function tests (creatinine \> 1,5N, transaminases \> 2N, bilirubin \> 1,5N) * Cardiac failure (ejection fraction \< 50%) * Lung disease or perturbed ventilation tests

What they're measuring

Progression free survival

Timeframe: 3 year

Trial details

NCT IDNCT00931645

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-12

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