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RECRUITING
NCT02508038
PHASE1

Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

This phase I trial studies the safety of transplantation with a haploidentical donor peripheral blood stem cell graft depleted of TCRαβ+ cells and CD19+ cells in conjunction with the immunomodulating drug, Zoledronate, given in the post-transplant period to treat pediatric patients with relapsed or refractory hematologic malignancies or high risk solid tumors.

Official title: TCR-αβ+ and CD19+ Depleted KIR/KIR Ligand-mismatched Haploidentical Hematopoietic Stem Cell Transplant and Zoledronate for Pediatric Relapsed/Refractory Hematologic Malignancies and High Risk Solid Tumors

Key Details

Gender

All

Age Range

7 Months - 21 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2016-02-12

Completion Date

2027-12

Last Updated

2025-10-16

Healthy Volunteers

No

Interventions

PROCEDURE

TCRαβ+/CD19+ depleted Haploidentical HSCT

Patients with high-risk leukemia will receive myeloablative conditioning. All other patients will undergo a reduced-intensity conditioning with ATG, Fludarabine, Thiotepa and Melphalan followed by transplant with a KIR/KIR (Killer cell immunoglobulin-like recetptor) ligand mismatched haploidentical donor peripheral blood stem cell graft depleted of TCRab+ cells and CD19+ cells using the CliniMACS System.

DRUG

Zoledronate

Given IV. Patients will receive five doses of Zoledronate (each 1.25 mg/m2 at a 28 day interval) following transplant.

Locations (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States