OncoMatch/Clinical Trials/NCT06918431
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Is NCT06918431 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for b acute lymphoblastic leukemia, philadelphia chromosome negative.
Treatment: Asparaginase Erwinia chrysanthemi · Cyclophosphamide · Cytarabine · Cytarabine · Daunorubicin Hydrochloride · Dexamethasone · Mercaptopurine · Methotrexate · Rituximab · Vincristine Sulfate — This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by consolidation chemotherapy in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. 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, and is used with other drugs 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. Induction therapy, consisting of cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, and rituximab, is the first choice of treatment. Consolidation therapy, consisting of cyclophosphamide, cytarabine, vincristine, mercaptopurine, methotrexate and rituximab, is given after initial therapy to kill any remaining cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Cytarabine and mercaptopurine stop cells from making DNA and may kill cancer cells. They are a type of antimetabolite. Daunorubicin blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. It is a type of anthracycline antibiotic and a type of topoisomerase inhibitor. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving asparaginase Erwinia chrysanthemi with induction chemotherapy followed by consolidation chemotherapy may be safe, tolerable, and/or effective in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: BCR fusion
Known presence of Philadelphia chromosome positive (Ph+; t[9;22])
Allowed: CD20 expression
CD20+ patients only: White blood cell count less than 25 x 10^9/L prior to initiation of rituximab
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: asparaginase
Received previous treatment with any other asparaginase formulation
Cannot have received: chemotherapy
Exception: Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study; prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed
Leukemia-based therapy with chemotherapy with the exception of: Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study; prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed
Lab requirements
Blood counts
Prothrombin (PT) ≤ 1.5 ULN; Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN
Kidney function
Creatinine clearance of ≥ 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN); AST ≤ 3.0 x ULN (≤ 5.0 x ULN if related to underlying leukemia); ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if related to underlying leukemia)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%; No class III/IV cardiovascular disability (NYHA); No history of acute cardiovascular ischemic event (myocardial infarction or unstable angina) within 6 months; No clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment
Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN); AST ≤ 3.0 x ULN (≤ 5.0 x ULN if related to underlying leukemia); ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if related to underlying leukemia); Creatinine clearance of ≥ 60 mL/min; Prothrombin (PT) ≤ 1.5 ULN; Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN; Left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope at Phoenix · Phoenix, Arizona
- City of Hope Medical Center · Duarte, California
- City of Hope at Irvine Lennar · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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