RecruitingPhase 1NCT02508038

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

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


Sponsor

University of Wisconsin, Madison

Enrollment

22 participants

Start Date

Feb 12, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 7 MonthsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a type of stem cell transplant from a half-matched family donor (called a haploidentical transplant) combined with a bone-strengthening drug (Zometa) for children and young people with blood cancers or solid tumors who don't have a perfectly matched donor available. **You may be eligible if...** - You are a child or young adult with a blood cancer (like leukemia or lymphoma) or certain solid tumors (like neuroblastoma or sarcoma) that has relapsed or not responded to treatment - You do not have a fully matched bone marrow donor available, or finding one would take too long - A half-matched family member is available to donate stem cells - Your heart, liver, and kidneys are functioning adequately - You have no uncontrolled infections - Your general health score is 60 or higher (on standard medical performance scales) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are HIV-positive - You have had a prior organ transplant (not stem cell) - You have heart failure or a serious uncontrolled infection - You have a serious unrelated illness that significantly increases your transplant risk - You are enrolled in another clinical trial that might affect results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETCRαβ+/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.

DRUGZoledronate

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

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NCT02508038


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