RecruitingPhase IIEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek od 18 do 39 lat z wskaźnikiem masy ciała powyżej 30, lub wiek 40-54 lata bez względu na wagę
  • •Nowo zdiagnozowana białaczka lymphoblastyczna (typ bez chromosomu Philadelphia) lub chłoniak lymphoblastyczny
  • •Ogólny stan zdrowia pozwalający na leczenie (wskaźnik ECOG nie wyższy niż 2)
  • •Sprawna praca wątroby - stężenie bilirubiny nie wyższe niż 1,5 razy норма
  • •Sprawna praca nerek - oczyszczanie kreatyniny co najmniej 60 mL/min na dobę
  • •Prawidłowe parametry krwawienia - wyniki badań PT i aPTT w normie
  • •Sprawna praca serca - wyrzutność lewej komory co najmniej 50%
  • •Brak aktywnego zapalenia wątroby typu B

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
54 Years
Last updated (source)
October 13, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (8)

City of Hope at Phoenix

Phoenix, United States

City of Hope Medical Center

Duarte, United States

City of Hope at Irvine Lennar

Irvine, United States

UC San Diego Moores Cancer Center

La Jolla, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, United States

University of Chicago Comprehensive Cancer Center

Chicago, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Cleveland Clinic Foundation

Cleveland, United States

Trial contact

Tibor Kovacsovics, MD

Ibrahim Aldoss

PRINCIPAL_INVESTIGATOR

James K. Mangan

James K. Mangan

PRINCIPAL_INVESTIGATOR

Patricia A. Young

Patricia A. Young

PRINCIPAL_INVESTIGATOR

Wendy Stock

PRINCIPAL_INVESTIGATOR

Mark B. Geyer

Mark B. Geyer

PRINCIPAL_INVESTIGATOR

Anjali S. Advani

Anjali S. Advani

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.

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