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

ConditionsAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaHodgkin LymphomaNon-Hodgkin LymphomaMyelodysplastic SyndromeMyeloproliferative SyndromeRhabdomyosarcomaEwing SarcomaPrimitive Neuroectodermal TumorOsteosarcomaNeuroblastoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • TCRαβ+/CD19+ depleted Haploidentical HSCT

    Procedure/Surgery

    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.

  • Zoledronate

    Drug

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

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: TCRαβ+/CD19+ depleted Haploidentical HSCT+ ZoledronateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of acute graft versus host disease (GVHD)

Time frame
Within 100 days post-transplantation
2

Incidence of graft failure

Time frame
At day 28

Secondary outcomes

1

Immune reconstitution

Immune reconstitution outcomes, as determined by immune cell analysis.

Time frame
Up to 1 year
2

Performance of the CliniMACS Reagent System utilizing the CliniMACS TCRαβ-biotin and CliniMACS CD19 reagent to produce a graft with defined cell content.

The performance of the CliniMACS Reagent System will be evaluated by measuring the number of viable stem cells, TCRαβ+ cells, TCRγδ+ cells, NK cells and B cells in the hematopoietic stem cell graft.

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov
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