Eligibility Module

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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: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT05066412
Eligibility Criteria: Inclusion Criteria: * Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies * Written informed consent of patient and donor obtained Exclusion Criteria: * Participant taking Prednisone (or equivalent steroid) * Participant taking Prednisone (or equivalent steroid) * Participant taking Mycophenolate Mofetil * Participant taking Cyclosporine/tacrolimus at therapeutic blood levels * Progressive hematologic malignancy before transplant * Second allogeneic transplant * Acute GvHD ≥ grade 2 * Chronic moderate or severe GvHD (NIH consensus criteria) * Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria) * Donor aberrant CD45RA expression due to a polymorphism in CD45 gene * Participation in another interventional clinical trial within 30 days prior to inclusion * Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion * Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT05066412
Study Brief:
Protocol Section: NCT05066412