Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04746209
Phase
PHASE2
Status
Recruiting
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Conditions

  • B-Cell ALL, Childhood
  • B-cell Acute Lymphoblastic Leukemia
  • B-cell Childhood Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Alpha/Beta T-cell and B-cell depleted HCT — DEVICE
    Device: Alpha/Beta T-cell and B-cell depletion
  • Blinatumomab — DRUG
    28 day continuous infusion given on Day 100 post-HCT if no significant ongoing GVHD

Study Details

This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.

Key Dates

Start date
Feb 1, 2021
Status verified
Sep 2021
Primary completion
Feb 28, 2024
Completion
Dec 31, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alpha/beta T-cell and B-cell Depleted, Myeloablative HCT
    Patients who are MRD Negative by Flow cytometry but are MRD Positive by High Throughput Sequencing, will receive a myeloablative conditioning regimen which includes total body irradiation (TBI) followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD.
  • Experimental: Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCT
    Patients who are MRD Negative by Flow cytometry and are MRD Negative by High Throughput Sequencing, will receive a reduced intensity conditioning regimen followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD.

Primary Outcome Measure

Percentage of patients who are able to receive the blinatumomab infusion [Feasibility] [ Time Frame: Day +100 post-HCT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of WisconsinMilwaukeeWisconsin53226
Meredith Beversdorf, RN
[email protected]
414-266-5891
Emily Ruszkiewicz, BS
[email protected]
414-266-4092
Rachel Phelan, MD, MPH (PRINCIPAL_INVESTIGATOR)
Julie-An Talano, MD (SUB_INVESTIGATOR)

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By research site
Children's Hospital of Wisconsin· Milwaukee, WI

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