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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00866307
First received: March 19, 2009
Last updated: July 15, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Drug: pegaspargase
Drug: cytarabine
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: prednisone
Drug: dexamethasone
Drug: methotrexate
Drug: daunorubicin hydrochloride
Drug: mercaptopurine
Drug: thioguanine
Radiation: prophylactic cranial irradiation
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Percentage of patients which tolerate at least 8 of the 12-14 total doses of pegaspargase. Safety measured by the percentage of High Risk-patients taking less than 49 weeks from Day 1 of Consolidation to Day 1 of Maintenance therapy. [ Time Frame: Up to 49 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 165
Study Start Date: February 2009
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Risk - Average (Day 29 MRD < 0.01%)
Cyclophosphamide IV days 1 & 29; cytarabine IV subcutaneously (SC) days 1-4, 8-11, 29-32, & 36-39; mercaptopurine PO once daily (QD) days 1-14 & 29-42; vincristine sulfate IV days 15, 22, 43, & 50; methotrexate IT days 1, 8, 15, & 22; & pegaspargase IV days 15 & 43. Int. Maint.: Vincristine sulfate IV days 1, 11, 21, 31, & 41; methotrexate IV days 1, 11, 21, 31, & 41; methotrexate IT days 1 & 31; and pegaspargase IV days 2 & 22. Delayed Intensification: Vincristine sulfate IV days 1, 8, 15, 43, & 50; dexamethasone IV or PO days 1-7 & 15-21; doxorubicin hydrochloride IV days 1, 8, & 15; cyclophosphamide IV day 29; cytarabine IV or SC days 29-32 & 36-39; thioguanine PO days 29-42; methotrexate IT days 1, 29, & 36; and pegaspargase IV days 4 & 43. Maint. begins day 57 of DI: Vincristine sulfate IV days 1, 29, & 57; prednisone PO days 1-5, 29-33, & 57-61; mercaptopurine PO days 1-84; methotrexate IT day 1; and methotrexate PO days 8, 15, 22, 29*, 36, 43, 50, 57, 64, 71, & 78.
Drug: pegaspargase
Given IV
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: cytarabine
Given IT and IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: prednisone
Given IV or PO
Other Names:
  • DeCortin
  • Deltra
Drug: dexamethasone
Given IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: methotrexate
Given IT and PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: thioguanine
Given PO
Other Name: 6-TG
Radiation: prophylactic cranial irradiation
Undergo radiation
Other Name: PCI
Other: laboratory biomarker analysis
Correlative studies
Experimental: High Risk - High (Day 29 MRD ≥ 0.01%) or other factors
Cyclophosphamide, cytarabine, mercaptopurine, vincristine sulfate, and methotrexate as in group A. Beginning on day 1, pegaspargase IV every 2 weeks. Patients with CNS3 disease undergo cranial radiotherapy QD for 10 days and patients with testicular disease undergo testicular radiotherapy QD for 12 days, beginning on day 1 of consolidation. Interim Maintenance: Patients receive vincristine sulfate and methotrexate as in group A. Beginning on day 1, pegaspargase IV every 2 weeks. Delayed Intensification: Vincristine sulfate, dexamethasone, doxorubicin hydrochloride, cyclophosphamide, cytarabine, thioguanine, and methotrexate as in group A. Beginning on day 1, pegaspargase IV over 1-2 hours every 2 weeks. Maint. begins day 57 of DI: Vincristine sulfate IV days 1, 29, & 57; prednisone PO days 1-5, 29-33, & 57-61; mercaptopurine PO days 1-84; methotrexate IT day 1; and methotrexate PO days 8, 15, 22, 29*, 36, 43, 50, 57, 64, 71, & 78.
Drug: pegaspargase
Given IV
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: cytarabine
Given IT and IV or SC
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: prednisone
Given IV or PO
Other Names:
  • DeCortin
  • Deltra
Drug: dexamethasone
Given IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: methotrexate
Given IT and PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: thioguanine
Given PO
Other Name: 6-TG
Radiation: prophylactic cranial irradiation
Undergo radiation
Other Name: PCI
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866307

Locations
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
United States, California
Miller Children's Hospital
Long Beach, California, United States, 90806
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States, 94143
United States, Florida
Nemours Children's Clinic-Jacksonville South
Jacksonville, Florida, United States, 32207
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Michigan
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
United States, New York
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oregon
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6008
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: ZoAnn Dreyer, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00866307     History of Changes
Other Study ID Numbers: AALL08P1  NCI-2009-01169  COG-AALL08P1  CDR0000636174  AALL08P1  AALL08P1  U10CA098543 
Study First Received: March 19, 2009
Last Updated: July 15, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Dexamethasone 21-phosphate
Liposomal doxorubicin
Pegaspargase
Cyclophosphamide
Methotrexate
Doxorubicin
Cytarabine
Vincristine
Daunorubicin
Asparaginase
6-Mercaptopurine
Thioguanine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016