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Donor-Derived NK Cell Infusions for High-Risk AML in Children and Young Adults

This study is looking at a new treatment for children and young adults (up to 25 years old) with high-risk acute myeloid leukemia (AML), a type of blood cancer. It's testing if adding "HaploNK cells" (natural killer cells from a donor) to a standard stem cell transplant can help prevent the cancer from coming back. You might be able to join if you have high-risk AML that is currently in remission (CR1) and have certain high-risk features. The study aims to see how well this treatment works by tracking how many participants are still cancer-free after one year. This study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is a Phase II pilot study, meaning it's an early-stage study looking at the effectiveness of the treatment. It plans to enroll 30 participants.
What's involved
Peripheral blood will be drawn from the donor at least 16 days before the scheduled transplant. The study involves three fixed doses of HaploNK cell infusions.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how many participants are cancer-free one year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04836390

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

Enrolling by Invitation
PHASE2Ages 0–25InterventionalTreatment
Michael Pulsipher
~30 participants
Updated 2025-05-04 on ClinicalTrials.gov
What's tested:Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions

At a glance

Recruiting sites
0 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1-year RFS
Measured over 1 year

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

13 sites across 11 states
Florida2
Ohio2
Arizona1
California1
Colorado1
Illinois1
Missouri1
New York1

Study leadership

  • Michael L Pulsipher, MD · STUDY_DIRECTOR · Children's Hospital Los Angeles

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≤ 25 years at time of enrollment
High-risk AML, as defined by one of the following:
AML in CR1 (defined as \<5% blasts in BM by morphology and flow cytometry) having at least one of these high-risk features:
Mutations associated with high risk disease (Appendix A). Other high-risk features not explicitly stated in Appendix A can be considered after discussion/approval with the protocol chair/team
MRD-positive at the end of Induction I chemotherapy (defined as flow cytometry ≥ 0.1% blasts)
AML in ≥CR2 (defined by \<5% blasts in BM by morphology and flow cytometry)
Recovery from prior cycle of chemotherapy as defined by an absolute neutrophil count ≥ 500/mm3
AML secondary to select germline marrow failure disorders (with exception of Fanconi Anemia) may be eligible but require approval from Protocol Chairs prior to enrollment.
Performance status ≥70% (Lansky for \<16 years; Karnofsky for ≥16 years)
Adequate major organ system function as demonstrated by:
Renal: Creatinine clearance (CrCl) ≥60 mL/min/1.73m2 by Cockcroft-Gault formula, Schwartz formula, or nuclear GFR study (Table 3)
Hepatic: Total bilirubin \<2 mg/dL (unless due to Gilbert syndrome) and ALT and AST \< 5x ULN
Cardiac: LVEF at rest ≥50% or SF ≥27% (by MUGA or ECHO)
Pulmonary: DLCO, FEV1, and FVC ≥ 50% of predicted corrected for hemoglobin. For patients \<7 years of age or those unable to perform PFTs: O2 Sat \>92% on room air by pulse oximetry and on no supplemental O2 at rest
The patient, patient's parent, guardian, or legal representative can provide written informed consent

Exclusion

Active extramedullary disease
Unresolved/ongoing and serious viral, bacterial, or fungal infection despite appropriate treatment
Positive pregnancy test in a female of child-bearing potential (FCBP)
Inability to comply with medical therapy or follow-up
Prior allogeneic transplant
Patients with Fanconi Anemia and Down syndrome

What this trial measures

  • 1-year RFS1 year

    The proportion and corresponding 95% exact binomial CI of patients who are relapse-free at 1-year from day of transplant (Day 0)