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NCT04166929: Bigeminy

Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS

Terminated Phase 2 Last updated 4 October 2023
What this trial tests

Phase 2 trial testing Haplo SCT with NK cells in Acute Myeloid Leukemia in 6 participants. Terminated before completion.

Timeline
15 January 2020
Primary endpoint
28 September 2023
28 September 2023

Quick facts

Lead sponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment6
Start date15 January 2020
Primary completion28 September 2023
Estimated completion28 September 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Adults 18 to 75, any sex, with Acute Myeloid Leukemia or Myelodysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Relapse after an allogeneic hematopoietic stem cell transplantation (HSCT) is high in patients with advanced AML, in the 50% range. NK cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced AML. Investigators hypothesize that the administration of a purified boost of NK cells on day +7 post HSCT, will reduce the incidence of relapse from the current 50% to 25%. In a phase III multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor NK cells on day +7 post-HSCT. The first 10 patients in the experimental arm will be analyzed for toxicity. The stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received NK cells.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
    Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5
  2. Natural killer cell-based immunotherapy for acute myeloid leukemia.
    Xu J, Niu T. · · 2020 · cited 83× · PMID 33287858 · DOI 10.1186/s13045-020-00996-x
  3. Natural killer cells and acute myeloid leukemia: promises and challenges.
    Rahmani S, Yazdanpanah N, Rezaei N. · · 2022 · cited 20× · PMID 35639116 · DOI 10.1007/s00262-022-03217-1
  4. Novel agents targeting leukemia cells and immune microenvironment for prevention and treatment of relapse of acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation.
    Shi W, Jin W, Xia L, Hu Y. · · 2020 · cited 15× · PMID 32837873 · DOI 10.1016/j.apsb.2020.06.012
  5. NK cell-based immunotherapy strategies for myeloid leukemia.
    Zhang L, Zhao Y, Dong Y, Jiang X. · · 2025 · cited 4× · PMID 40726987 · DOI 10.3389/fimmu.2025.1621885

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

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Data sources for this page

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