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Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia

NCT00931645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2009-07-02

No results posted yet for this study

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).

Conditions

  • Chronic Lymphocytic Leukemia

Interventions

PROCEDURE

Autologous stem cell transplantation

TBI (10 grays, d-3-1), cyclophosphamide (60 mg/sqm d-5-4)

PROCEDURE

DHAP rescue and Autologous stem cell transplantation

DHAP :IV cisplatin 100 mg/sqm d1, IV cytarabine 2 g/sqm d2,, IV dexamethasone 40 mg/sqm d1-4, TBI (10 grays d-3-1), cyclophosphamide (60 mg/sqm d-5-4)

PROCEDURE

DHAP rescue and F+C

DHAP :IV cisplatin 100 mg/sqm d1, IV Cytarabine 2 g/sqm d2, IV dexamethasone 40 mg/sqm d1-4, Followed by 3 monthly cycles with IV d1-3 fludarabine (25 mg/sqm) \& cyclophosphamide (300 mg/sqm)

Sponsors & Collaborators

  • Direction Générale de la Santé, France

    collaborator OTHER

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Sutton Laurent, MD · Hospital Victor Dupouy Argenteuil, France

  • Leporrier Michel, MD · CaenUH, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2007-12-31
Completion
2008-12-31

Countries

  • France

Study Locations

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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 NCT00931645 on ClinicalTrials.gov