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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorSt. Jude Children's Research Hospital

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

Treatment groups

30 Participants
are divided into 1 treatment group