KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT Children

Part of paid clinical trials in Los Angeles, California.

Sponsor
Michael Pulsipher
Study ID
NCT02646839
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • CliniMacs TCR alpha-beta-Biotin system — DEVICE
    Graft ex vivo depleted of T cell receptor (TCR) αβ+CD3+/CD19+ cells

Study Details

This is a phase II, open-label, non-randomized, prospective study of haploidentical transplantation using KIR-favorable donors for children with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT). The relationship of KIR2DL1 polymorphisms to survival in children with these diseases undergoing any approach to allogeneic HCT during the study time frame will also be determined.

Key Dates

Start date
Oct 31, 2015
Status verified
May 2025
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: KIR Favorable Transplant
    To assess in a multi-center setting whether the disease-free survival (DFS) at one-year post-HCT for children with high-risk ALL, AML and MDS can be improved following favorably KIR-mismatched haplo-HCT using a graft ex vivo depleted of T cell receptor (TCR) αβ+CD3+/CD19+ cells from CliniMacs TCR alpha-beta-Biotin system

Primary Outcome Measure

Disease free survival at 1 year post HCT [ Time Frame: 1 year ]

Locations (11)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital OaklandOaklandCalifornia94609-
Stanford University Medical CenterPalo AltoCalifornia94305-
Rady Children's HospitalSan DiegoCalifornia92123-
University of California, San FranciscoSan FranciscoCalifornia94143-
Lurie Children's HospitalChicagoIllinois60611-
New York Medical CenterValhallaNew York10595-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Vanderbilt University - Monroe Carell Jr. Children's HospitalNashvilleTennessee37232-
University of Utah, Primary Children's HospitalSalt Lake CityUtah84112-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Oakland· Oakland, CAStanford University Medical Center· Palo Alto, CARady Children's Hospital· San Diego, CAUniversity of California, San Francisco· San Francisco, CALurie Children's Hospital· Chicago, IL

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