Reduced Intensity Conditioning Allogeneic Transplantation for CLL With Preemptive MDR Management (ICLL 03 RICAC-PMM)
18 Years
70 Years
Both
Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma
Trial Information
Reduced Intensity Conditioning Allogeneic Transplantation for CLL With Preemptive MDR Management (ICLL 03 RICAC-PMM)
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 Globulin) : 2.5 mg/kg/day on Day-2 and Day-1
Preemptive immunointervention post AHSCT consists in reduce immunosuppressive treatment more
or less associated with DLI according to :
- the presence or absence of severe Graft versus host disease (GVHD) (acute grade 2 and /
or chronic)
- the presence or absence of a response on criteria of response IWCLL
- Getting or not a blood MRD negative (<-10 ^ -4) evaluated by flow cytometry
Inclusion Criteria:
- 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)
1. No response or relapse within 12 months of treatment with purine analogues
(including "fludarabine refractory" i.e patients in response
2. relapse within 24 months after combination therapy including purine analogs or
autograft, with indication of new start of treatment
3. 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MRD(Minimal Residual Disease) negativity level
Outcome Time Frame:
12 months after AHSCT(Allogenic Transplantation of Hematopoietic Stem Cells Transplantation)
Safety Issue:
No
Principal Investigator
Olivier Tournilhac
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Clermont-Ferrand
Authority:
France: Ministry of Health
Study ID:
CHU-0150
NCT ID:
NCT01849939
Start Date:
September 2012
Completion Date:
September 2017
Related Keywords:
- Chronic Lymphocytic Leukemia
- Lymphocytic Lymphoma
- Allogeneic transplantation of hematopoietic stem cells transplantation
- Chronic Lymphocytic Leukemia
- Donor Lymphocyte Injection
- Preemptive immunointervention
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
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