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

Conditions

• B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
• Lymphoblastic Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 54 Years

Healthy Volunteers

Not accepted

Interventions

• Asparaginase Erwinia chrysanthemi — DRUG
  Given IM
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration and/or biopsy
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow aspiration and/or biopsy
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• Cyclophosphamide — DRUG
  Given IV
• Cytarabine — DRUG
  Given IT
• Cytarabine — DRUG
  Given IV or SC
• Daunorubicin Hydrochloride — DRUG
  Given IV
• Dexamethasone — DRUG
  Given PO
• Echocardiography — PROCEDURE
  Undergo echocardiography
• Lumbar Puncture — PROCEDURE
  Undergo lumbar puncture
• Mercaptopurine — DRUG
  Given PO
• Methotrexate — DRUG
  Given IT
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Rituximab — BIOLOGICAL
  Given IV
• Vincristine Sulfate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Oct 10, 2025

Status verified

Mar 2026

Primary completion

Mar 30, 2029

Completion

Mar 30, 2029

Study Design

Enrollment

53 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (asparaginase Erwinia chrysanthemi)
  See Detailed Description

Primary Outcome Measure

Incidence of adverse events (AEs) (Safety Lead-in) [ Time Frame: Up to completion of induction cycle (cycle length = 28 days) ]

Locations (8)

Find similar trials in Phoenix, AZ

Related Studies

• Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
  Recruiting · Children's Oncology Group · Birmingham, Alabama
• Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
  PHASE2 · Recruiting · Fred Hutchinson Cancer Center · Los Angeles, California
• Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
  Recruiting · Northwestern University · Chicago, Illinois