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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

ConditionHematologic Malignancy
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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Thymoglobulin

    Drug

    IV

  • Cyclophosphamide

    Drug

    IV

  • Fludarabine

    Drug

    IV

  • Thiotepa

    Drug

    IV

  • Melphalan

    Drug

    IV

  • Mesna

    Drug

    IV

  • Filgrastim

    Drug

    IV

  • Blinatumomab

    Drug

    IV

  • CliniMACS

    Device

    The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HAP3HCT TreatmentExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Number of participants experiencing grade 3-4 GVHD and/or transplant related mortality (TRM).

Safety will be measured by monitoring for the incidence of grade 3-4 GVHD as well as any transplant related mortality experience. Feasibility monitoring will include 1) failure to receive protocol directed DLI among the evaluable participants; and 2) the number of days from transplant infusion to DLI infusion among evaluable participants.

Time frame
Within 100 days post-transplant infusion

Secondary outcomes

1

Number of participants experiencing safety issues or feasibility concerns related to blinatumomab administration.

Safety and feasibility will be measured by monitoring for any early discontinuation of blinatumomab.

Time frame
Within 180 days post-transplant infusion
2

Describing pharmacokinetics of rabbit ATG in participants.

Measuring concentration of rabbit ATG levels in participants at the specified time points within the protocol.

Time frame
Within 14 days post-transplant infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Jude Children's Research Hospital

Lead sponsor

Source ClinicalTrials.gov
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