Clinical trial · Interventional
T-cell Depleted Donor Lymphocyte Infusion (DLI)for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
Preemptive CD8+ T-cell Depleted Donor Lymphocyte Infusion (DLI) Following Nonmyeloablative Stem Cell Transplantation (NMT) for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
- 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)
Primary Objectives: This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell donor lymphocyte infusion (DLI) in: * Reducing the incidence of graft versus host disease (GVHD) based on standard classification of acute and chronic GVHD * Improving hte disease remission rate in comparison with our previous study results. Secondary Objectives: * To investigate the impact of CD8+ depleted T-cell DLI in hematopoietic chimerism, and immunologic recovery of transplant patients.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD8+ T-cell depleted donor lymphocyte infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Incidence rate of acute and chronic GVHD
- measure
- Disease remission rate post CD8+ depleted T-cell DLI
Secondary outcomes (1)
- measure
- Hematopoietic chimerism and immunologic recovery post CD8+ depleted T-cell DLI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of AML or high risk MDS in the following disease stages: Induction failure, first or subsequent remission, or untreated first relapse. 2. Patient must have an HLA-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (HLA-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor) 3. Both patient and donor must sign written informed consent forms. 4. Patients must have: * ECOG PS \</= 2; * Ejective fraction \> 40%; * DLCO \> 40% of predicted; * Serum bilirubin \</= 1.5x institutional upper limit of normal; * SGPT (ALT) and SGOT (AST) \</= 2.5x institutional upper limit of normal; * Serum creatinine \</= 2x upper limit of normal; * Creatinine clearance \>/= 60mL/min. However, renal dysfunction is not an absolute contraindication for NMT as dialysis can be performed during NMT. Exclusion Criteria: 1. Not fulfilling any of the inclusion criteria 2. Active life-threatening infection 3. Overt untreated infection 4. HIV positivity, hepatitis B or C antigen positivity with active hepatitis 5. Pregnant or lactating women 6. Donor contraindication (HIV seropositive confirmed by Western blot; hepatitis B antigenemia) 7. Unable to donate bone marrow or peripheral blood due to concurrent medical condition
References
Publications (0)
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