Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: 2-Aminopurine; 6-Mercaptopurine; Asparaginase; BB 1101; Cortisone; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Pegaspargase; Prednisone; Thioguanine; Vincristine

Criteria

Inclusion Criteria:

• Patients must be eligible for and enrolled on AALL08B1 or the successor classification study

• Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization [WHO] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia)

• White blood cell (WBC) >= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids

• 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; (Note: 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 this study; the dose and duration of previous steroid therapy should be carefully documented

• Pregnancy tests with a negative result must be obtained in all post-menarchal females

• Lactating females must agree that they will not breastfeed a child while on this study

Exclusion Criteria:

• Patients with Down syndrome are excluded from this study

• Patients with testicular leukemia at diagnosis are excluded from this study

• Pregnant female patients are excluded from this study