Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

Completed · Phase 1

Conditions studied: Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia

In brief

This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.

Key facts

Study ID

NCT00866307

Run by

Children's Oncology Group

People needed

104

Starts

2009-02-23

Expected to finish

2021-03-31

Last updated by the study team

2021-04-27

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be eligible for and enrolled on AALL03B1 or the successor classification study
• Patients must have newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL)
• WBC criteria
• Age 1.00-9.99 years: WBC >= 50,000/uL
• Age 10.00 - 30.99 years: Any WBC
• Prior steroid therapy: Any WBC
• Patients with testicular leukemia: Any WBC
• Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
• Intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
• Patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

You may not qualify if…

• Pregnant female patients are ineligible; pregnancy tests with a negative result must be obtained in all post-menarchal females; males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; lactating females must agree that they will not breastfeed a child while on this study
• Patients with Down syndrome (DS) are ineligible since excessive toxicities and death have been noted for those enrolled on AALL0232 receiving the prednisone/Capizzi methotrexate (PC) arm of treatment, which is the backbone regimen for the current study

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Harbor-University of California at Los Angeles Medical Center — Torrance, California, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• Advocate Children's Hospital-Oak Lawn — Oak Lawn, Illinois, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• The Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Dayton Children's Hospital — Dayton, Ohio, United States
• Legacy Emanuel Children's Hospital — Portland, Oregon, United States
• Legacy Emanuel Hospital and Health Center — Portland, Oregon, United States
• Children's Oncology Group — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
• Methodist Children's Hospital of South Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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