Allogeneic HCT With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings

Inclusion Criteria

PATIENT

• Diseases

Hematological malignancies confirmed histologically and not rapidly progressing:

• AML in CR (defined as ≤ 5% marrow blasts and absence of blasts in the peripheral blood);
• MDS with ≤ 5% marrow blasts and absence of blasts in the peripheral blood;
• CML in CP;
• MPS not in blast crisis and not with extensive marrow fibrosis,
• ALL in CR;
• Multiple myeloma not rapidly progressing;
• CLL;
• Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
• Hodgkin's disease with chemosensitive disease.
• Clinical situations
• Theoretical indication for a standard allo-transplant, but not feasible because:
• Age > 50 yrs;
• Unacceptable end organ performance;
• Patient's refusal.
• Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.
• Other inclusion criteria
• Male or female; fertile patients must use a reliable contraception method;
• Age 15 Kg (because of leukapheresis);
• Fulfills criteria for allogeneic PBSC donation according to standard procedures;
• Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.

Exclusion Criteria

PATIENT

• Any condition not fulfilling inclusion criteria;
• HIV positive;
• Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT.
• Life expectancy severely limited by disease other than malignancy;
• Administration of cytotoxic agent(s) for "cytoreduction" within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
• CNS involvement with disease refractory to intrathecal chemotherapy.
• Terminal organ failure, except for renal failure (dialysis acceptable)
• Uncontrolled infection;
• Karnofsky Performance Score <70%;
• Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;
• Patient is a female who is pregnant or breastfeeding;
• Previous radiation therapy precluding the use of 2 Gy TBI or 8 Gy TLI;

DONOR

• Any condition not fulfilling inclusion criteria;
• Unable to undergo leukapheresis because of poor vein access or other reasons.