Informations générales (source: ClinicalTrials.gov)
Reduced Intensity Conditioning Allogeneic Transplantation for CLL With Preemptive MDR Management (ICLL 03 RICAC-PMM) (RICAC)
Interventional
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
septembre 2012
septembre 2017
29 juin 2024
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 prognostic factors permits early determination of the high risk
population and provide them the therapeutic intensification. Allogeneic transplantation
of hematopoietic stem cells transplantation (AHSCT) allows to long-term remission and in
some cases complete and definitive eradication of the disease. After chemotherapy or
antibodies, the Minimal Residual Disease (MRD) negativity is associated with better
disease-free survival. MRD negativity occurs in some patients with the appearance of
GVHD, stopping the immunosuppression or after donor lymphocyte injection (DLI). The
negativity of MRD in the first year post-transplant is correlated with better
progression-free survival or overall survival (Dreger 2010, Farina 2009, Caballero 2005,
Algrin, 2011). So, MRD negativity may be an objective after AHSCT. The aim of this
prospective study is to evaluate a standardized preemptive immunointervention of
post-allograft immunosuppressive therapy modulation and DLI administration according to
MRD level. The objective is to obtain MRD negativity at 12 months after AHSCT.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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 <PR and / or
relapse within 6 months after at least 2 courses of Fludurabine)
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
- 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 <PR and / or
relapse within 6 months after at least 2 courses of Fludurabine)
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
- 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