Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

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 ID
NCT04746209
Phase
PHASE2
Sponsor
Medical College of Wisconsin
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Alpha/Beta T-cell and B-cell depleted HCT
  • Blinatumomab
Locations (sample)
  • Milwaukee, Wisconsin, United States|43.0389,-87.90647

Key Eligibility Criteria

  • Diagnosis of B-ALL with no evidence of minimal residual disease in the bone marrow by multi-parameter flow cytometry (FC-MRD negative, \<0.01%) and…
  • In remission after first relapse or greater (≥ CR2)
  • Very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL)
  • First remission with persistent disease identified as end of consolidation (EOC) MRD \> 0.01%.

For full eligibility, visit ClinicalTrials.gov.

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