Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia

This phase I/Ib trial tests the safety and side effects of asparaginase Erwinia chrysanthemi-recombinant-rywn (recombinant Erwinia asparaginase) and venetoclax in combination with blinatumomab and how well the combination works in treating patients with CD19 positive B-cell acute lymphoblastic leukemia (ALL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia c

Trial Details

NCT ID
NCT07133997
Phase
PHASE1
Sponsor
City of Hope Medical Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Asparaginase Erwinia chrysanthemi
  • Biospecimen Collection
  • Blinatumomab
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Cyclophosphamide
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729

Key Eligibility Criteria

  • Documented informed consent of the participant and/or legally authorized representative
  • Age between 12 and 55
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70
  • Patients with relapsed or refractory (R/R) CD19 positive (+) B-cell acute lymphoblastic leukemia (B-ALL) according to World Health Organization (WH…

For full eligibility, visit ClinicalTrials.gov.

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