Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT00504803
Eligibility Criteria:
V.1. Patients
V.1.1. Diseases
Hematological malignancies confirmed histologically and not rapidly progressing:
* AML in CR;
* ALL in CR;
* CML unresponsive/intolerant to Imatinib but not in blast crisis;
* Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis;
* MDS with \< 5% blasts;
* Multiple myeloma;
* CLL;
* Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
* Hodgkin's disease.
V.1.2. Clinical situations
* Theoretical indication for a standard allo-transplant, but not feasible because:
* 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.
V.1.3. Other inclusion criteria
* Male or female; fertile female patients must use a reliable contraception method;
* Age \< 75 yrs.
* Informed consent given by patient or his/her guardian if of minor age.
V.1.4. Exclusion criteria
* Any condition not fulfilling inclusion criteria;
* HIV positive;
* Terminal organ failure, except for renal failure (dialysis acceptable);
* Uncontrolled infection, arrhythmia or hypertension;
* Previous radiation therapy precluding the use of 2 Gy TBI;
* HLA-identical donor.
V.2. PBSC donors
V.2.1. Inclusion criteria
* Related to the recipient (sibling, parent or child) or unrelated;
* Male or female;
* Weight \> 15 Kg (because of leukapheresis);
* Fulfills generally accepted criteria for allogeneic PBSC donation;
* Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.
V.2.2. Exclusion criteria
* Any condition not fulfilling inclusion criteria;
* HIV positive;
* Unable to undergo leukapheresis because of poor vein access or other reasons.
V.2.3. HLA matching
Related or unrelated donors who have 1-2 HLA mismatches, as either :
* One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
* One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
* Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
* One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.
* One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1
V.3. Cord blood unit
Banked cord blood units will be used if they fulfill the following criteria:
* No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1)
* \> 2.5 x 107 TNC/kg
* Standard validation by FACT/Netcord criteria.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00504803
Study Brief:
Protocol Section:
NCT00504803