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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Michael Pulsipher
Study ID
NCT04836390
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions — DRUG
    Peripheral blood (PB) ≤ 450 mL and based on donor weight (minimum 10 ml/kg) will be drawn from the HLA-haploidentical donor at least 16 days before the scheduled day of transplant (Day 0). HaploNK cells will be manufactured from the PB of the donor after co-culture with irradiated feeder cells (IFC) as described in Section 2.4. The recipients will receive three NK cell infusions on Day-1, Day+7 (± 1 day) and Day+42 (up to Day+90) from day of transplant (Day 0).

Study Details

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.

Key Dates

Start date
Aug 24, 2021
Status verified
Nov 2024
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    All subjects will receive NK infusions.

Primary Outcome Measure

1-year RFS [ Time Frame: 1 year ]

Locations (13)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital ColoradoAuroraColorado80045-
AdventHealth OrlandoOrlandoFlorida32803-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
Ann & Robert H. Lurie Children's HospitalChicagoIllinois60611-
Washington University, St. LouisSt LouisMissouri63110-
New York Medical CollegeValhallaNew York10595-
Cleveland Clinic Lerner College of MedicineClevelandOhio44195-
Nationwide Children's HospitalColumbusOhio43205-
University of UtahSalt Lake CityUtah84112-
Fred Hutchinson Cancer CenterSeattleWashington95109-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Phoenix Children's Hospital· Phoenix, AZChildren's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Aurora, COAdventHealth Orlando· Orlando, FLJohns Hopkins All Children's Hospital· St. Petersburg, FLAnn & Robert H. Lurie Children's Hospital· Chicago, IL

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