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Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia
Sponsor: City of Hope Medical Center
Summary
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 chrysanthemi. It is used in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a drug used to treat certain types of B-cell acute lymphoblastic leukemia that are CD19 positive (expresses the protein CD19). Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. Blinatumomab is a type of bispecific T-cell engager. Giving asparaginase Erwinia chrysanthemi and venetoclax in combination with blinatumomab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory ALL.
Official title: A Phase 1/1b Study Evaluating Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) and Venetoclax in Combination With Blinatumomab in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Key Details
Gender
All
Age Range
12 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2026-06-01
Completion Date
2028-06-01
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
Asparaginase Erwinia chrysanthemi
Given IM
Biospecimen Collection
Undergo blood sample collection
Blinatumomab
Given CIV
Bone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
Cyclophosphamide
Given cyclophosphamide
Echocardiography Test
Undergo ECHO
Lumbar Puncture
Undergo lumbar puncture
Multigated Acquisition Scan
Undergo MUGA
Venetoclax
Given PO
Vincristine
Given vincristine
Locations (1)
City of Hope Medical Center
Duarte, California, United States