Actively Recruiting
A Phase 2 Study Evaluating the Safety and Efficacy of Asparaginase Erwinia Chrysanthemi-Recombinant-Rywn During Pediatric-Inspired Regimen in High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Led by City of Hope Medical Center · Updated on 2026-03-17
53
Participants Needed
8
Research Sites
N/A
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
Researchers are studying high-risk adults aged 18 to 54 with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) that is Philadelphia chromosome negative. The trial evaluates the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi combined with chemotherapy during initial treatment. This phase II trial aims to understand how this enzyme-based drug, which may stop cancer growth, works when given with other chemotherapy drugs in patients who cannot take asparaginase from E. coli. Participants receive induction therapy including drugs like cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, rituximab (for CD20 positive patients), and asparaginase Erwinia chrysanthemi given intramuscularly on specific days over four weeks. Those with certain disease features may continue with extended induction therapy. Afterwards, consolidation therapy lasts about eight weeks with cyclophosphamide, cytarabine, mercaptopurine, vincristine, methotrexate, rituximab (if CD20 positive), and possibly additional doses of asparaginase Erwinia chrysanthemi. Treatment adjusts based on disease progression and tolerance. During the study, patients undergo various tests including blood samples, bone marrow biopsies, lumbar punctures, echocardiograms, and CT or PET/CT scans. Researchers closely monitor safety by tracking adverse events and specific liver-related problems, and measure treatment response including remission rates and minimal residual disease. Follow-up occurs 30 days after treatment ends to assess ongoing safety and outcomes.
CONDITIONS
Brief Title
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by participant or legal representative
- Age between 18 and 39 years with BMI of 30 or higher, or age 40 to 54 years regardless of BMI
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Newly diagnosed Philadelphia chromosome negative acute lymphoblastic leukemia or lymphoblastic lymphoma as defined by WHO criteria
- Both B-cell and T-cell types allowed
- For CD20 positive patients, white blood cell count less than 25 x 10^9/L before starting rituximab
- Total bilirubin less than or equal to 1.5 times upper limit of normal unless Gilbert's disease or leukemia-related
- AST less than or equal to 3.0 times upper limit of normal (or 5.0 if leukemia-related) before treatment
- ALT less than or equal to 3.0 times upper limit of normal (or 5.0 if leukemia-related) before treatment
- Creatinine clearance of at least 60 mL/min by urine test or formula
- Prothrombin time (PT) less than or equal to 1.5 times upper limit of normal
- Activated partial thromboplastin time (aPTT) less than or equal to 1.5 times upper limit of normal
- Left ventricular ejection fraction (LVEF) of 50% or higher confirmed by echocardiogram
- CD20 positive patients must be seronegative for active hepatitis B virus
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and after study as specified
You will not qualify if you...
- Prior leukemia therapy except limited cytoreduction or intrathecal chemotherapy allowed before study
- Previous treatment with any asparaginase formulation
- Receiving or planning to receive live vaccines during study or shortly before/after
- Presence of Philadelphia chromosome positive leukemia
- Severe heart failure (Class III/IV) or unstable arrhythmias
- Central nervous system involvement by leukemia
- Recent significant cardiovascular events within 6 months
- History of severe pancreatitis
- History of alcohol overuse if relevant
- Allergic reactions to similar compounds
- Uncontrolled active infections or illnesses
- Other active cancers
- Pregnant or breastfeeding women
- Any condition or situation that may prevent safe participation or compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive a combination of chemotherapy drugs including asparaginase Erwinia chrysanthemi, cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, and for some, rituximab over a 4-week period to treat their leukemia or lymphoblastic lymphoma.
Multiple visits during the 4-week period for drug administration and assessments
Duration - Up to 16 days
Participants with specific bone marrow response receive additional treatment with chemotherapy drugs including asparaginase Erwinia chrysanthemi, dexamethasone, vincristine, and daunorubicin over up to 16 days if disease progression or unacceptable toxicity do not occur.
Multiple visits during the extended induction period
Duration - 8 weeks
Participants receive further chemotherapy including cyclophosphamide, cytarabine, mercaptopurine, vincristine, methotrexate, and possibly rituximab and asparaginase Erwinia chrysanthemi over an 8-week period to consolidate treatment response.
Multiple visits during the 8-week consolidation period
Duration - 30 days
After completing study treatment, participants are followed up to monitor their health and any lasting effects of treatment.
1 follow-up visit at 30 days post-treatment
Trial Site Locations
Total: 8 locations
1
City of Hope at Phoenix
Phoenix, Arizona, United States, 85338
Actively Recruiting
2
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Not Yet Recruiting
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Not Yet Recruiting
5
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
6
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
8
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet 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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