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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT03887156
Eligibility Criteria:
Inclusion Criteria:
* PATIENT :
* Age between 18 and 65 years ( included )
* Being candidate to a graft of peripheral hematopoietic stem cells , according the following criteria :
* HLA compatibility 10 / 10 with the selected donor
* Malignant haematological disorder as described below :
* Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia ( ALL) in 1st or 2d complete remission
* Aggressive lymphoma in complete remission
* Non - progressive myeloproliferative syndrome ,
* Myelodysplasia with stable blasts is cell number and \< 10 % of blastocysts,
* Acute leukemia biphenotypic in 1st or 2d complete remission
* Sequential graft conditioning, myeloablative or with a reduced intensity, both may include ATG
* Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not being opposed to medical data collection DONOR
* Adult ( ≥ 18 year old) up to the maximum authorized by each National Transplantation Authority
* Being a patient's sibling or registered in the Bone Marrow Donors Worldwide registry or a national registry
* Being candidate to a Peripheral Blood Stem Cells donation with a Human Leucocyt Antigen (HLA) 10 / 10 compatibility with the recipient ,
* Signed and dated informed consent ( in accordance with local regulation of the country in which the observation is performed )
Exclusion Criteria:
* Participating in a clinical trial, if interventional on the prophylaxis treatment ( not on the prophylaxis ) of GVHD, in the 30 days prior to the inclusion and during the Predictor 2 study ,
* Being placed under legal supervision ,
* Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03887156
Study Brief:
Protocol Section:
NCT03887156