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Reduced Intensity Conditioning Allogeneic Transplantation for CLL With Preemptive MDR Management (ICLL 03 RICAC-PMM)

Phase 2
18 Years
70 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma

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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 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

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:


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:


Principal Investigator

Olivier Tournilhac

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Clermont-Ferrand


France: Ministry of Health

Study ID:




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