Status:
COMPLETED
Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Eligibility:
All Genders
2-30 years
Phase:
PHASE3
Brief 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 chemoth...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the pharmacokinetic comparability of EZN-2285 (calaspargase pegol) compared to Oncaspar (pegaspargase) given intravenously during induction and consolidation in pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00671034
Start Date
July 21 2008
End Date
March 31 2021
Last Update
April 27 2021
Active Locations (27)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045