Actively Recruiting
Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia
Led by City of Hope Medical Center · Updated on 2026-04-07
26
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 55 years
- Relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia with 5% blasts in bone marrow
- ECOG performance status 2 or Karnofsky performance status 70
- White blood cell count under 25 x 10^9/L before starting venetoclax
- Total bilirubin 1.5 times upper limit of normal or 3 times if Gilbert's disease or leukemia present
- Prothrombin time and partial thromboplastin time 1.5 times upper limit of normal
- AST and ALT 2.5 times upper limit of normal or 5 times if related to leukemia
- Creatinine clearance 60 mL/min by urine test or Cockcroft-Gault formula
- Left ventricular ejection fraction 50%
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during study and for 3 months after last dose
You will not qualify if you...
- Allogeneic hematopoietic cell transplantation within 8 weeks before starting study treatment
- Cancer chemotherapy within 2 weeks before starting study except intrathecal or low-dose maintenance
- Use of strong/moderate CYP3A4 inducers or strong CYP3A inhibitors within 7 days before treatment
- Consumption of foods/supplements that affect CYP3A within 3 days before and during treatment
- Immunotherapy within 4 weeks before treatment except prior CD19 therapy ended more than 4 weeks ago
- Live vaccine use during study or 2 weeks before/after treatment
- Prior intolerance to pegylated asparaginase causing severe pancreatitis or CNS thrombosis
- Active central nervous system leukemia or CNS leukemia signs without prior clearance
- Active graft versus host disease needing immunosuppressive treatment
- History of intracranial or recurrent thrombosis or severe pulmonary embolism
- History of severe pancreatitis
- History of alcohol overuse if relevant
- Known allergy to blinatumomab or recombinant Erwinia asparaginase
- Uncontrolled active infection or serious uncontrolled illness
- Other active cancers except certain early-stage skin or prostate conditions
- Pregnant or breastfeeding females
- Any condition that makes participation unsafe or infeasible according to investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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