Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial
Malignant diseases confirmed histologically and not rapidly progressing:
- Hematologic malignancies
- CML and other myeloproliferative disorders;
- Multiple myeloma;
- Non-Hodgkin's lymphoma;
- Hodgkin's disease.
- Non-hematologic malignancies
- Renal cell carcinoma (metastatic).
1.2. Inclusion criteria
- Male or female; female patients must use a reliable contraception method;
- Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);
- HIV negative;
- No terminal organ failure;
- No uncontrolled infection, arrhythmia or hypertension;
- Family donor (HLA-identical) or unrelated donor (matched for A-B by low
resolution typing and for DRB1-DQB1 by high resolution typing);
- No previous radiation therapy precluding the use of 2 Gy TBI
- Informed consent given by patient or his/her guardian if of minor age.
1.3. Clinical situations
- Theoretical disease indication for a standard allo-transplant, but not feasible
- Age > 55 yrs;
- Unacceptable end organ performance;
- Patient's refusal.
- Indication for a standard auto-transplant:
- perform mini-allotransplantation 2-6 months after standard autotransplant.
- Not an indication for intensification but a potential candidate for cellular
2.1. Inclusion criteria
- Related to the recipient (sibling, parent or child) or unrelated;
- Male or female;
- Weight > 15 Kg (because of leukapheresis);
- HIV negative;
- No major contraindication for allogeneic PBSC donation by generally accepted
- Informed consent given by donor or his/her guardian if of minor age.
2.2. Exclusion criteria
- Any condition not fulfilling inclusion criteria;
- Unable to undergo leukapheresis because of poor vein access or other reasons.