Clinical trial · Interventional
CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission
A Randomized Trial Comparing CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy in Older Adults With Acute Myelogenous Leukemia in First Complete Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study was abandoned and a new study was written to replace this one
Summary
Brief summary (as posted)
This is a phase II trial designed to test the safety and efficacy (disease free survival \[DFS\]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML). The natural killer (NK) cell product will be given to patients 60 years and older who are in a first complete remission after 1 or 2 courses of standard AML induction. After a preparative regimen of cyclophosphamide and fludarabine, patients will receive a single infusion of either CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aldesleukin | Drug | Aldesleukin | ALIAS |
| CD3-/CD19- natural killer cells | Biological | — | UNRESOLVED |
| CD3-CD56+ natural killer cells | Biological | — | UNRESOLVED |
| CliniMACS® CD3 and CD19 Reagent System | Device | — | UNRESOLVED |
| CliniMACS® CD56 Reagent System | Device | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients Using CD3-/CD19- NK cell product
- description
- Patients receive the apheresis product (collected day -1: enriched for NK cells using the CliniMACS® CD3 and CD19 Reagent System in combination with the large-scale tubing set (Miltenyi Biotec) to simultaneously deplete CD3+ cells to remove T-lymphocytes and deplete CD19+ cells to remove B-lymphocytes (CD3-/CD19- natural killer cells). Patients will also receive Cyclophosphamide, Fludarabine and Aldesleukin.
- interventionNames
- Biological: CD3-/CD19- natural killer cells
- Device: CliniMACS® CD3 and CD19 Reagent System
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Aldesleukin
- type
- EXPERIMENTAL
- label
- Patients Using CD3-/CD56+ purified NK cell product
- description
- Patients receive the apheresis product (collected day -1): purified for NK cells using the CliniMACS® CD3 Reagent System (Miltenyi Biotec) in combination with the large-scale tubing set to deplete CD3+ cells and then use the CliniMACS® CD56 Reagent System to enrich CD56+ NK cells (CD3-CD56+ natural killer cells). Patients will also receive Cyclophosphamide, Fludarabine and Aldesleukin.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of acute myelogenous leukemia (except acute promyelocytic leukemia) in a first complete remission (CR1) and meet the following criteria: * Meets the definition of complete remission by morphologic criteria including \<5% blasts in a moderately cellular (\> 20% cellularity) or cellular marrow. * Complete remission (CR) was achieved after no more than 2 cycles of standard induction chemotherapy. Early re-induction therapy based on residual disease on a day 14 bone marrow (BM) will count as a 2nd cycle. Prior therapy with demethylating agents (i.e. azacitidine) is allowed, but patients must have attained CR after standard cytotoxic therapy (defined as absolute neutrophil count (ANC) \> 1000 cells/μL, platelets \> 100 x 10\^9/L) * No more than 3 months have lapsed from attainment of CR1 * No acute myelogenous leukemia (AML) consolidation therapy administered prior to enrollment * Not a candidate for allogeneic stem cell transplantation * ≥ 60 years of age * Karnofsky performance status ≥ 70% * Available related HLA haploidentical natural killer (NK) cell donor (sibling, offspring, or offspring of an HLA identical sibling) by at least Class I serologic typing at the A\&B locus (donor age 18-75 years) * At least 30 days since last dose of chemotherapy * Adequate organ function within 14 days of enrollment defined as: * Creatinine: ≤ 2.0 mg/dL * Hepatic: aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) \< 5 x upper limit of institutional normal (ULN) * Pulmonary: oxygen saturation ≥ 90% on room air * Cardiac: left ventricular ejection fraction (LVEF) by echocardiogram (ECHO or MUGA) ≥ 40%, no uncontrolled angina, uncontrolled atrial or ventricular arrhythmias, or evidence of acute ischemia or active conduction system abnormalities (rate controlled a-fib is not an exclusion) * Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to the NK cell infusion (excluding preparative regimen pre-meds) * Voluntary written consent Exclusion Criteria: * Biphenotypic acute leukemia * New progressive pulmonary infiltrates on screening chest x-ray or chest Computed Tomography scan that has not been evaluated with bronchoscopy (when feasible). Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections). * Uncontrolled bacterial, fungal, or viral infections including human immunodeficiency virus (HIV) - chronic asymptomatic viral hepatitis is allowed * Pleural effusion large enough to be detectable on chest x-ray * Known hypersensitivity to one or more of the study agents Donor Selection: * Related donor (sibling, offspring, or offspring of an HLA identical sibling) 18-75 years of age * At least 40 kilograms * In general good health as determined by the medical provider * Negative for hepatitis and HIV on donor viral screen * HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A\&B locus * Not pregnant * Voluntary written consent
References
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