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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT04180059
Eligibility Criteria:
Inclusion Criteria:
* Patients HLA-DPB1\*04:01 positive, with confirmed diagnosis of hematologic malignancies (AML, Myelodysplasic and myeloproliferative syndrome, ALL, non-Hodgkin's lymphoma, Hodgkin's disease, CLL), undergoing an allo-HSCT using a HLA-DPB1\*04:01 negative donor.
* The graft can be PBSC (peripheric blood stem cells) or bone marrow.
* Patients aged between 18-75 years.
* Patients in complete remission or \>50% of response (for lymphoma) at time of transplant.
* have a donor with no contra-indications for mobilization of peripheral blood stem cells using G-CSF (colony-stimulating factors)
* Affiliation number to the National Health Care System
* Lack of reactivity of the clone against the donor's cells (PHA-blasts prepared for from PBMCs).
* For cord blood transplants: cord blood must be HLA-DPB1\*04:01 negative and the HLA compatibility (A, B, DR) between the cord blood and the recipient must be 4/6, 5/6 or 6/6.
* ECOG \<=2 or Karnofsky \>60%
* neutrophils ≥ 1 000 cells /μl and/or platelets ≥ 50 000 cells/μl (growth factor allowed)
Exclusion Criteria:
* pregnant or breastfeeding woman
* patient refusing contraception measure
* minor
* Adult patients under guardianship, curatorship or justice protection
* Patients with post-transplant relapse within the clone injection time (before D100)
* Karnofsky performance score below 60%or ECOG \>2
* Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease.
* Severe liver failure (bilirubin \>30 µmoles/L, SGPT (Serum Glutamo-Oxalacetic Transaminase)\> 4 X upper limit of normal).
* Impaired renal function (creatinine clearance \< 30 ml/min)
* Acute GVHD \> grade 1
* Active uncontrolled infection.
* Denied to provide informed consent
* Severe neurological or psychiatric disorders as determined by the study physician.
* Treatment with other investigational drugs following allogeneic transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04180059
Study Brief:
Protocol Section:
NCT04180059