Clinical trial · Interventional
Randomized Study of Haploidentical Hct and Subsequent Donor nk Cell Infusion in High-risk AML and MDS
Randomized Comparative Study for Efficacy and Safety Evaluation of HLA-haploidentical Hematopoietic Cell Transplantation With or Without Post-transplant Allogeneic Donor-derived Natural Killer Cell Infusion in High-risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): upon recommendation from the Data Monitoring Committee
Summary
Brief summary (as posted)
This is a single center, open label, random comparison phase 2b study. The primary objective of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic, donor-derived natural killer (NK) cells infused after HLA-haploidentical hematopoietic cell transplantation (HCT) in patients with refractory acute myelogenous leukemia (AML). The secondary objectives of the study are to assess the side effects of donor NK cell infusion, effects of donor NK cell infusion upon HCT outcomes, as well as effects upon post-HCT immune recovery.
Conditions
Conditions (1)
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 Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic, donor-derived NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment
- description
- patients will receive donor-derived NK cell infusion after haploidentical HCT
- interventionNames
- Biological: allogeneic, donor-derived NK cells
- type
- NO_INTERVENTION
- label
- control
- description
- patients will undergo haploidentical HCT but not receive donor-derived NK cells after HCT
Primary outcomes (1)
- measure
- number of patients who experience progression/recurrence of AML after HCT
- timeFrame
- up to 60 months
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with refractory AML Refractory AML is defined as follows; 1. Primary refractory: failure to achieve complete remission (CR) after 2 cycles of induction chemotherapy; or, in patient ≥65 years of age, progressive AML after treatment with hypomethylating agent (increase in peripheral blood blast by 50% or increase in bone marrow blast by 25%) 2. Relapse then refractory: recurrence of AML, which is refractory to standard salvage chemo therapy; or, in patient ≥65 years of age, to hypomethylating agent 3. AML in ≥2 relapses * Patients should be 19 years of age or older * Patients should have Karnofsky performance scale ≥70 * Patients and cell donors must understand fully and sign informed consent forms Exclusion Criteria: * Pregnant or lactating women * Patient with abnormal liver function (total bilirubin ≥ 5.0 mg/dl, AST ≥ 5 times upper normal limits) * Patients with abnormal renal function (creatinine ≥ 3.0 mg/dl) * Patients with clinically-evident cardiac or pulmonary dysfunction * Patients with infection that is progressive despite appropriate anti-microbial treatment * Patients with hypersensitivity to gentamicin * Patients who had received allogeneic cell therapy previously.
References
Publications (1)
- DERIVEDLee KH, Yoon SR, Gong JR, Choi EJ, Kim HS, Park CJ, Yun SC, Park SY, Jung SJ, Kim H, Lee SY, Jung H, Byun JE, Kim M, Kim SY, Kim JH, Lee JH, Lee JH, Choi Y, Park HS, Lee YS, Kang YA, Jeon M, Woo J, Kang H, Baek S, Kim SM, Kim HM, Cho KH, Choi I. The infusion of ex vivo, interleukin-15 and -21-activated donor NK cells after haploidentical HCT in high-risk AML and MDS patients-a randomized trial. Leukemia. 2023 Apr;37(4):807-819. doi: 10.1038/s41375-023-01849-5. Epub 2023 Mar 17. PMID 36932165