Status:
UNKNOWN
Eradication of Residual Disease by Preemptive Immunointervention After Allogeneic Hematopoietic Stem Cells Transplantation in Chronic Lymphocytic Leukemia
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Pierre Fabre Laboratories
Conditions:
Chronic Lymphocytic Leukemia
Lymphocytic Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However, the diagnosis in young patients become more frequently with poor prognosis. The identification of new prognost...
Detailed Description
Patients will receive AHSCT with Fludarabine-Busulfan based conditioning : * Fludarabine : 30 mg/m2/day - from Day-6 to Day-2 * Busulfan IV : 3.2 mg/kg/day - on Day-5 and Day-4 * ATG (Anti-thymocyte ...
Eligibility Criteria
Inclusion
- Patients with CLL (Matutes score 4 or 5) stages A, B, C with evolution criteria according IWCLL 2008 or lymphocytic lymphoma with severity criteria (EBMT criteria) which indicated allograft (deletion 17p) and requiring treatment
- Age: 18-70 years
- At least one of the following criteria of poor prognosis (EBMT recommendations - Dreger 2007)
- No response or relapse within 12 months of treatment with purine analogues (including "fludarabine refractory" i.e patients in response \<PR and / or relapse within 6 months after at least 2 courses of Fludurabine)
- relapse within 24 months after combination therapy including purine analogs or autograft, with indication of new start of treatment
- Mutation/deletion 17p13 (p53) with indication for treatment
- Partial response (PR) or complete response (CR) at the last treatment (IWCLL 2008)
- Residual mass \<5 cm (clinical and CT scan)
- Identical intrafamilial donor HLA (or with a mismatch) or in the absence of family donor, an unrelated donor 10/10 for HLA A, B, C, DR, DQ and is committed to giving DLI (see consent form donor)
- Sorror score comorbidity: ≤ 2
- Written informed consent
- Member or beneficiary of a social security system
Exclusion
- Richter Syndrome
- Usual contraindications for realisation of allogeneic transplantation including
- Uncontrolled bacterial, viral or fungal infection
- Pregnancy or lactating women
- Cardiac contraindication : Cardiac ejection fraction \<50%
- Pulmonary contraindication : DLCO \<50%
- Renal contraindication : Creatininine clearance \<30 ml / min
- Hepatic contraindication : AST and / or ALT and / or total bilirubine\> 2 N except Gilbert disease or localisation specific LLC
- HIV positivity
- Cancer evolution or de novo occurred in the previous 5 years except basal cell cancer skin or carcinoma in situ of the cervix of uterus
- Affection psychiatric disease
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01849939
Start Date
September 1 2012
End Date
September 1 2017
Last Update
May 9 2013
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003