Status:
COMPLETED
Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Direction Générale de la Santé, France
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 tr...
Detailed Description
All registered patients will be treated with 6 monthly courses of chemotherapy. First three ones will be a CHOP regimen with half dosage of adriamycin, as previously published (Effectiveness of "CHOP"...
Eligibility Criteria
Inclusion
- patients with stage B \& C CLL, 18- 65 years.
- previously untreated
- given written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00931645
Start Date
April 1 2001
End Date
December 1 2008
Last Update
July 2 2009
Active Locations (1)
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1
DBIM Hopital Saint Louis
Paris, France, 75000