About this trial
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.
Eligibility criteria
Qualifiers
Age less than or equal to 21 years
High risk ALL in CR1 or CR2,
any ALL in CR3 or subsequent;
AML in high risk CR1 (AML diagnosis includes myeloid sarcoma),
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
Received an autologous HCT within the previous 6 months
Trial design
Treatments tested in this trial
- Thymoglobulin
- Cyclophosphamide
- Fludarabine
- Thiotepa
- Melphalan
- Mesna
- Filgrastim
- Blinatumomab
- CliniMACS