Study on Asparaginase Erwinia Chrysanthemi with Chemotherapy for Treating High-Risk Adults with Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06918431

Provider View

This clinical trial is testing the safety and effectiveness of a drug called asparaginase Erwinia chrysanthemi, used with chemotherapy, for adults with high-risk acute lymphoblastic leukemia or lymphoblastic lymphoma who cannot use a similar drug from E. coli.

Patient Parameters

Program Overview

This study is exploring whether a drug called asparaginase Erwinia chrysanthemi, when combined with chemotherapy, is safe and effective for treating adults with high-risk acute lymphoblastic leukemia or lymphoblastic lymphoma. This drug is used for patients who cannot take a similar drug made from E. coli. It works by breaking down a substance cancer cells need to grow, potentially stopping their growth or killing them. The treatment involves two phases: induction therapy, which is the initial treatment, and consolidation therapy, which follows to eliminate any remaining cancer cells.

Description

Primary Objectives:

  • To check the safety of asparaginase Erwinia chrysanthemi when used with initial chemotherapy by monitoring side effects and their severity.
  • To see how many patients experience severe liver issues related to the study drug during the initial treatment phase.

Secondary Objectives:

  • To further assess the safety of the drug during the initial treatment phase.
  • To evaluate how many patients achieve complete remission after the initial treatment.
  • To determine the rate of patients with no minimal residual disease (MRD) after initial treatment.
  • To see how many patients can proceed to further treatment phases within 42 days of starting.
  • To evaluate MRD negativity after consolidation therapy.
  • To monitor the duration of severe liver issues.

Exploratory Objectives:

  • To assess the safety of the drug during extended and consolidation therapy phases.
  • To evaluate the molecular profile and its association with treatment response.

Treatment Plan:

  • Induction (Cycle 1): Patients receive a combination of drugs including cytarabine, dexamethasone, vincristine, daunorubicin, asparaginase Erwinia chrysanthemi, methotrexate, and rituximab (for CD20 positive patients). Treatment lasts 4 weeks unless there is disease progression or unacceptable side effects.
  • Extended Induction (Cycle 1A): For patients needing further treatment, additional drugs are given over a few weeks.
  • Consolidation (Cycle 2): Patients receive a different combination of drugs over 8 weeks to target any remaining cancer cells.

Patients will undergo various tests and procedures throughout the study to monitor their health and treatment response. After completing the study treatment, follow-up occurs at 30 days.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent.
  • Age 18-39 with a BMI of 30 or more, or age 40-54 regardless of BMI.
  • Good overall health with an ECOG score of 2 or less.
  • Newly diagnosed with Philadelphia-negative acute lymphoblastic leukemia or lymphoblastic lymphoma.
  • CD20 positive patients must have a white blood cell count below a certain level before starting rituximab.
  • Meet specific liver and kidney function criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a period after.
  • Men and women must agree to use effective birth control or abstain from sex during the study and for a period after.

Exclusion Criteria

  • Previous leukemia treatment, except for certain allowed medications.
  • Prior use of any asparaginase formulation.
  • Recent or planned live vaccinations.
  • Presence of Philadelphia chromosome positive leukemia.
  • Severe heart conditions or recent heart events.
  • Central nervous system involvement.
  • Significant heart rhythm issues.
  • History of severe pancreatitis or alcohol overuse.
  • Allergic reactions to similar drugs.
  • Uncontrolled infections or other serious illnesses.
  • Pregnant or breastfeeding women.
  • Any condition that might interfere with study participation.

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