Clinical trial · Interventional
Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia
Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia
- 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)
RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| in vitro treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intent-to-Treat
- description
- All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10\^7/kg.)
- interventionNames
- Biological: aldesleukin
- Biological: therapeutic allogeneic lymphocytes
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Procedure: in vitro treated peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Number of Patients With Natural Killer (NK) Cell Expansion
- timeFrame
- Study Day 14
- description
- Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (\>100 donor-derived NK cells per uL of patient blood detectable at day +14).
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria: * Primary refractory disease (no complete response \[CR\] after ≥ 2 induction therapies) * Relapsed disease not in CR after ≥ 1 course of standard reinduction therapy * Secondary AML from myelodysplastic syndromes * Disease relapsed ≥ 2 months after transplant and no option of donor lymphocyte infusions (e.g., recipients of autologous or umbilical cord blood transplants) * Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after at least one cycle of standard chemotherapy and imatinib * Over 60 years of age with relapse within 6 months after completion of last chemotherapy * Over 60 years of age with blast count \< 30% within 10 days before study entry * Related HLA-haploidentical natural killer cell donor available * No severe organ damage (by clinical or laboratory assessment) * Performance status 50-100% * No evidence of active infection on chest X-ray * No active fungal infection Exclusion Criteria: * Active central nervous system (CNS) leukemia * Pleural effusions large enough to be detectable by chest x-ray * Pregnant or nursing (positive pregnancy test) * Fertile patients must use effective contraception * Less than 60 days since prior transplant * Less than 3 days since prior prednisone * Less than 3 days since other prior immunosuppressive medication
References
Publications (1)
- DERIVEDBachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9. PMID 24719405