Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
United States22 participantsStarted 2016-02-12
Plain-language 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.
Who can participate
Age range7 Months – 21 Years
SexALL
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Inclusion Criteria:
* 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
* Relapsed or primary therapy-refractory AML with bone marrow blast \< 20%
* High-risk refractory or relapsed ALL in patients for whom transplantation is deemed indicated (relapse occurring \< 30 months from diagnosis, patients relapsing after previous allogeneic transplant, relapse after 2nd remission, primary induction failure or hypodiploidy)
* Relapsed Hodgkin lymphoma unable to achieve 2nd remission or Very Good Partial Response (VGPR) and therefore ineligible to receive autologous hematopoietic stem cell transplant (auto-HSCT)
* Hodgkin lymphoma relapsing after auto-HSCT
* Primary refractory or relapsed non-Hodgkin lymphoma unable to achieve 2nd remission or VGPR and therefore ineligible to receive auto-HSCT
* Non-Hodgkin lymphoma relapsing after auto-HSCT
* Myelodysplastic Syndrome/Myeloproliferative Syndrome
Solid Tumor
* Patients with solid tumor must have failed or have been ineligible to receive auto-HSCT or if auto-HSCT would not offer \> 20% chance of cure
* Neurob…
What they're measuring
1
Incidence of acute graft versus host disease (GVHD)