Status:
COMPLETED
Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-30 years
Phase:
PHASE1
Brief Summary
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. P...
Detailed Description
PRIMARY OBJECTIVES: I. To demonstrate that biweekly intravenous (IV) pegaspargase beginning with Consolidation and ending with completion of delayed intensification (DI) in combination with hemi-augm...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00866307
Start Date
February 23 2009
End Date
March 31 2021
Last Update
April 27 2021
Active Locations (28)
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1
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
2
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Valley Children's Hospital
Madera, California, United States, 93636