About this trial
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL.
Primary Objective:
\- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.
Secondary Objectives:
* To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS). * To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.
Eligibility criteria
Qualifiers
Age less than or equal to 21 years
High risk CD19+ B cell ALL in CR1 or CR2
Any CD19+ B-cell ALL in CR3 or subsequent
If prior CNS leukemia, it must be treated and in CNS CR
Disqualifiers
Has a suitable HLA-identical sibling or suitable 12/12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame
Any other active malignancy other than the one for which this HCT is indicated
Received a prior allogeneic HCT at any time
Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment
Trial design
Treatments tested in this trial
- Anti-Thymocyte Globulin (Rabbit)
- Cyclophosphamide
- Fludarabine
- Thiotepa
- Mesna
- Melphalan
- Filgrastim
- CliniMACS System