Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Randomized Phase III Trial Evaluating the Role of Autologous Stem Cell Transplantation in Previously Untreated Patients With Stage B and C Chronic Lymphocytic Leukemia
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).
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" regimen in advanced untreated chronic lymphocytic leukemia. French
Cooperative Group on Chronic Lymphocytic Leukemia. Lancet ; 1986, i : 1346-1349), followed
by three subsequent courses with IV fludarabine (25 mg/sqm d1-5). Patients in CR (NCI, 1996,
including CAT scan evaluation) will be then randomized to surveillance without additional
treatment or autologous stem cell transplantation using peripheral stem cells collected
after the three first courses of chemotherapy, and/or after the completion of the six
courses when necessary. For patients not in CR after the six courses, a rescue regimen with
the DHAP association ( cisplatin, 100 mg/sqm d1, cytarabine 2 g/sqm d2, dexamethasone 40
mg/sqm d1-4) will precede an additional stem cell collection if necessary, and patient will
be randomized between autologous stem cell transplantation and three additional courses of
an association of fludarabine (25 mg/sqm d1-3) and cyclophosphamide (300 mg/sqm d1-3).
Conditioning regimen will associate TBI (10 grays, d -3-1) and cyclophosphamide (60 mg/sqm
d-5-4).
Evaluation for response wil be performed before randomisation and two months after
completion of therapy in each arm.
Follow-up data will be registered and monitored every three month during the first year, and
then every six month. Criteria for evaluation of response will use the NCI system (1996).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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