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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01853358
Eligibility Criteria:
Inclusion Criteria:
1. Patient treated with allogeneic stem cell transplantation
* Presenting an hematological malignancy with an intermediate, high or very high risk index according to the disease risk index developed by the Dana Farber Cancer Institute
* Donor: HLA matched related or unrelated (10/10) donor
* Graft: Peripheral stem cell transplant
* Reduced Intensity Conditioning as used in the current transplant program: Fludarabine, IV Busulfan and Thymoglobuline
2. Age above 18 and under 70
3. Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky index ≥ 70 %
4. Survival expectation \> 6 months
5. Affiliation to social security
6. Signed informed consent from Donor and Patient
Exclusion Criteria:
1. Active grade \>= 2 acute GVHD or corticotherapy ≥ 0.5 mg/kg/day at time of NK cell infusion
2. Active infection
3. Psychiatric disorder occurring after transplant
4. Pregnant or breast-feeding women or without contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01853358
Study Brief:
Protocol Section:
NCT01853358