NCT05066412 Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
| NCT ID | NCT05066412 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital, Geneva |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2026-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-11-26 with a primary completion date of 2026-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05066412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05066412 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05066412 currently recruiting?
Yes, NCT05066412 is actively recruiting participants. Contact the research team at anne-claire.mamez@hcuge.ch for enrollment information.
Where is the NCT05066412 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT05066412 clinical trial?
NCT05066412 is sponsored by University Hospital, Geneva. The trial plans to enroll 12 participants.