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Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

NCT04746209 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-09-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Alpha/Beta T-cell and B-cell depleted HCT

Device: Alpha/Beta T-cell and B-cell depletion

DRUG

Blinatumomab

28 day continuous infusion given on Day 100 post-HCT if no significant ongoing GVHD

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Rachel Phelan, MD, MPH · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-02-28
Completion
2029-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04746209 on ClinicalTrials.gov