TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies
St. Jude Children's Research Hospital
Summary
This is a phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI. The primary objective is: \- To assess the safety and feasibility of early CD45RA-depleted DLI administration. The secondary objectives are * To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy. * To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.
Description
The purpose of the study is to learn more about the effects (good and bad) of transplanting progenitor (blood making) cells and donor lymphocytes (white blood cells) donated by a partially matched family member that have been modified in a laboratory, to children and young adults with a high risk cancer that is in remission but is at high risk of relapse. This study builds upon what we have learned from recently completed studies and will be testing the safety and effects of the chemotherapy and the combination of two different types of blood cell infusions on the transplant recipient's diseas…
Eligibility
- Age range
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Recipient: * Age less than or equal to 21 years * High risk hematologic malignancy whereas allogeneic transplantation is the current standard of care. This includes (but is not limited to): * High risk ALL in CR1 or CR2, * any ALL in CR3 or subsequent; * AML in high risk CR1 (AML diagnosis includes myeloid sarcoma), * any AML in CR2 or subsequent, * any therapy related AML; * MDS (primary or secondary), * NK cell, biphenotypic, or undifferentiated leukemia/lymphoma in CR1 or subsequent; * CML in accelerated phase, or in chronic phase with persistent molec…
Interventions
- DrugThymoglobulin
IV
- DrugCyclophosphamide
IV
- DrugFludarabine
IV
- DrugThiotepa
IV
- DrugMelphalan
IV
- DrugMesna
IV
- DrugFilgrastim
IV
- DrugBlinatumomab
Location
- St. Jude Children's Research HospitalMemphis, Tennessee