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RecruitingPhase 2

Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

A Phase 2 Study Evaluating the Safety and Efficacy of Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) During Pediatric-Inspired Regimen in High-Risk Adults With Newly Diagnosed ALL or LBL

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 54 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks, 8 weeks
  • Procedures mentioned: Blood draws, CT scans, Biopsies, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity."
  • "Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity."
  • "Additionally, patients undergo echocardiography at screening and blood sample collection, bone marrow aspiration and/or biopsy, lumbar puncture, and computed tomography (CT) and/or positron emission tomography (PET)/CT throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety, side effects, and cancer-fighting effects of asparaginase Erwinia chrysanthemi given with chemotherapy. It is for high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma, cancers that affect white blood cells. Treatment has two stages: the first attacks the cancer, and the second aims to kill cancer cells left behind.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal representative must give written consent.
  • You must be ages 18–39 with a body mass index (BMI, a measure of weight compared with height) of at least 30, or ages 40–54 at any BMI.
  • You must have newly diagnosed leukemia or lymphoma listed above without the Philadelphia chromosome, a certain gene change. Both B-cell and T-cell types are allowed.
  • You must be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
  • Your liver, kidney, and blood-clotting tests must meet study limits. Your heart must pump out at least 50% of the blood in its main pumping chamber with each beat.
  • If your cancer has the CD20 protein, your white blood cell count must be below the study limit before rituximab. You must also have negative results on the required hepatitis B tests.
  • If you can become pregnant, you must have a negative pregnancy test.
  • If you or your partner could become pregnant, you must use effective non-hormonal birth control or avoid sex that could cause pregnancy during treatment and for at least 6 months afterward, or 12 months after the last rituximab dose.

Who can't join

  • You have already had leukemia chemotherapy or any form of asparaginase. Some early treatments are allowed: steroids, hydroxyurea, one chemotherapy dose into spinal fluid, or ATRA for suspected acute promyelocytic leukemia.
  • You have Philadelphia chromosome-positive cancer, cancer involving brain or spinal cord tissue, or another active cancer.
  • You have severe heart-related limits on activity, a serious or recently unstable heart rhythm problem, or a heart attack or unstable chest pain within 6 months.
  • You have had a blood clot inside the skull, repeated blood clots, a severe clot in the lungs, or severe inflammation of the pancreas. Catheter-related clots are an exception.
  • You have an uncontrolled infection or other serious uncontrolled illness, a relevant history of alcohol overuse, or an allergy to a substance similar to a study drug.
  • You have received or plan to receive a live vaccine during treatment or within 2 weeks before or after treatment. For CD20-positive cancer, any vaccine within 4 weeks before rituximab is also not allowed.
  • You are pregnant or breastfeeding.
  • The study doctor believes participation would be unsafe or you could not follow all study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age between 18 and 39 with body mass index (BMI) ≥ 30 or age 40-54 years, regardless of BMI * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Patients with newly diagnosed Philadelphia (Ph)-negative (-) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) according to World Health Organization (WHO) criteria * Both B- and T-cell phenotypes are allowed. * CD20+ patients only: White blood cell count less than 25 x 10\^9/L prior to initiation of rituximab (within 14 days prior to day 1 of protocol therapy) * Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN) * Aspartate aminotransferase (AST) ≤ 3.0 x ULN (AST ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy) * Note: AST ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration * Alanine aminotransferase (ALT) ≤ 3.0 x ULN (ALT ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy) * Note: ALT ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration * Creatinine clearance of ≥ 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy) * Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy) * Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy) * Left ventricular ejection fraction (LVEF) ≥ 50% * Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy * Seronegative for active hepatitis B virus (HBV) (surface antigen negative and anti-hepatitis B virus core antibody \[HBc\] negative) for CD20+ patients only * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy) * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential to use an effective (non-hormonal) method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy. For participants taking rituximab, effective birth control or abstinence to be used for at least 12 months after last dose * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * 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 * Received previous treatment with any other asparaginase formulation * Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+ patients only: Must not have received any vaccines (live or non-live) 4 weeks before rituximab * Known presence of Philadelphia chromosome positive (Ph+; t\[9;22\]) * Class III/IV cardiovascular disability according to the New York Heart Association classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll * Parenchymal central nervous system (CNS) involvement * Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment * History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment * History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis) * Participants with history of grade ≥ 3 pancreatitis * History of alcohol overuse if deemed relevant in investigator opinion * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Uncontrolled active infection * Clinically significant uncontrolled illness * Other active malignancy * Females only: Pregnant or breastfeeding * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Study sites (8)

AZ

CA

IL

NY

OH