Clinical trialNCT04836390Enrolling, by, invitationPhase 2Interventional

Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant

SponsorMichael PulsipherEnrollment30Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a Phase II pilot study to determine the efficacy of three fixed dose (1 x 108/kg) infusions of ex-vivo expanded human leukocyte antigen (HLA)-haploidentical donor natural killer (NK) cells (haploNK) in children and young adults with high risk acute myeloid leukemia (AML) undergoing HLA-haploidentical hematopoietic cell transplant (haploHCT) with a busulfan and cyclophosphamide-based myeloablative conditioning regimen and post-transplant cyclophosphamide (PTCy) for graft versus host disease (GVHD) prophylaxis. The investigators will also demonstrate the feasibility of performing this trial in a multi-center study. The investigators hypothesize that the infusion of haploNK in this setting will facilitate immune reconstitution and decrease relapse rates and infectious complications without increasing GVHD, resulting in improved survival as compared to recent historical cohorts of haploHCT without NK cell infusion.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Michael L Pulsipher, MD
Children's Hospital Los Angeles
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Phoenix Children'S Hospital
Phoenix, Arizona, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Adventhealth Orlando
Orlando, Florida, United States
Johns Hopkins All Children'S Hospital
St. Petersburg, Florida, United States
Ann & Robert H. Lurie Children'S Hospital
Chicago, Illinois, United States
Washington University, St. Louis
St Louis, Missouri, United States
New York Medical College
Valhalla, New York, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States
University of Utah
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Aug 2021
Primary completion: 31 May 2026
Completion: 31 May 2028
Last update posted: 4 May 2025
Registered enrollment: 30
Registry id: NCT04836390

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.