Clinical trial · Interventional
Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning
NCT05066412CI-TRIAL-00085912recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haplo-identical Stem Cell Transplantation | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Prophylactic CD45RA-depleted DLI
- interventionNames
- Other: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
Primary outcomes (2)
- measure
- acute transfusion reaction (CTCAE ≥ 2)
- timeFrame
- 24 hours after each CD45RA neg DLI infusion
- description
- acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)
- measure
- acute GvHD grade II-IV
- timeFrame
- within 8 weeks after each CD45RAneg DLI infusion
- description
- acute GvHD grade II-IV measured with MAGIC score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.