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

ConditionsAcute Myeloid Leukemia Acute Lymphoblastic Leukemia Hodgkin Lymphoma Non-Hodgkin Lymphoma Myelodysplastic Syndrome Myeloproliferative Syndrome Rhabdomyosarcoma Ewing Sarcoma Primitive Neuroectodermal Tumor Osteosarcoma Neuroblastoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age7-21

SponsorUniversity of Wisconsin, Madison

About this trial

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 criteria

Qualifiers

Availability of an eligible haploidentical donor

Hematologic malignancy or solid tumor

Patients with more than one malignancy (hematologic or solid tumor) are eligible

Patients with hematologic malignancy must have no HLA identical sibling or suitable unrelated donor OR time needed to find an acceptable unrelated donor match would likely result in disease progression such that the patient may become ineligible for any type of potentially curative transplant

Disqualifiers

Pregnant or breast-feeding

HIV infection

Heart failure or uncontrolled cardiac rhythm disturbance

Uncontrolled, Serious Active Infection

Trial design

Treatments tested in this trial

TCRαβ+/CD19+ depleted Haploidentical HSCT
Zoledronate

Treatment groups

22 Participants

are divided into 1 treatment group

Sponsors and collaborators

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov