Clinical trial · Interventional
Natural Killer (NK) Cell Transplantation for AML
Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia
NCT00187096CI-TRIAL-00014886completedN/AResults postedClinicalTrials.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)
The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS System | Device | — | UNRESOLVED |
| Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2 | Drug | — | UNRESOLVED |
| Natural Killer Cell Infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stratum 1
- description
- Stratum 1 (AML in complete remission) Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
- interventionNames
- Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2
- Procedure: Natural Killer Cell Infusion
- Device: CliniMACS System
- type
- EXPERIMENTAL
- label
- Stratum 2
- description
- Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease) Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.
- interventionNames
- Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with AML that is in complete remission, is relapsed or refractory, or with increasing minimal residual disease. * Participants in complete remission must have recovered from toxicity of previous therapy and have evidence of bone marrow recovery * Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD and 60 or more days have elapsed since the SCT. Exclusion Criteria: * Participants who are pregnant * Participants with inadequate renal, liver, or pulmonary functions
References
Publications (1)
- RESULTRubnitz JE, Inaba H, Ribeiro RC, Pounds S, Rooney B, Bell T, Pui CH, Leung W. NKAML: a pilot study to determine the safety and feasibility of haploidentical natural killer cell transplantation in childhood acute myeloid leukemia. J Clin Oncol. 2010 Feb 20;28(6):955-9. doi: 10.1200/JCO.2009.24.4590. Epub 2010 Jan 19. PMID 20085940