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Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 17, 2021 (before its estimated February 28, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Site contact updatedv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04746209
Lead Sponsor Medical College of Wisconsin
Collaborators: Amgen, University of Wisconsin, Madison
Conditions B-cell Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, B-Cell ALL, Childhood
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov