Donor mobilization : Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days. Hematopoïetic Stem Cell Harvest: By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ \>= 2 and \<= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG * D-5 : Fludarabine (30 mg/m²) * D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h) * D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h) * D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) * D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at 3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with an anti A/B antibodies titer\> 1/32. Transplant : HSC at D0 • 3 months after Transplantation : Disease Evaluation : * If CR : Supervision. Then if progression: 4 cycles of Bortezomib. * If no CR : Bortezomib (4 cycles) • Evaluation after Bortezomib cycles * If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
reduced intensity conditioning for allogenic transplant
Mohamad Sobh
Lyon, France
Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).
Time frame: 3 years
Haematological recovery
Time frame: 3 years
Engraftment rate and graft failure rate
Time frame: 3 years
The tolerance of Bortezomib after AlloHCST
Time frame: 5 years
CR (Complete Response) length rate defined by Bladé criteria.
Time frame: 5 years
Incidence and severity of acute and chronic GVHD
Time frame: 5 years
Outcome of GVHD under treatment by Bortezomib
Time frame: 5 years
Chimerism study by competitive PRC
Time frame: 5 years
Immunological study of the graft (ancillary study)
Time frame: 5 years
Study of immunological recovery by the recipient
Time frame: 5 years
TRM = Transplant- Related Mortality at 3 months
Time frame: 3 months
TRM = Transplant- Related Mortality at 1 year
Time frame: 1 year
Study of quality of life
Time frame: 5 years
Global survival at 3 years and 5 years
Time frame: 3 and 5 years
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