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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00866307
Recruitment Status : Unknown
Verified February 2017 by Children's Oncology Group.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2009
Results First Posted : December 7, 2016
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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. 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 or disease Intervention/treatment Phase
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study
Study Start Date : February 2009
Actual Primary Completion Date : June 30, 2014


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. AALL08P1 Safety Outcome [ Time Frame: Consolidation through Delayed Intensification ]
    Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.

  2. AALL08P1 Feasibility Outcome [ Time Frame: Consolidation through Delayed Intensification ]
    Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866307


Locations
Show Show 20 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: ZoAnn Dreyer, MD Children's Oncology Group
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00866307    
Other Study ID Numbers: AALL08P1
NCI-2009-01169 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AALL08P1 ( Other Identifier: Children's Oncology Group )
CDR0000636174 ( Other Identifier: ClinicalTrials.gov )
AALL08P1 ( Other Identifier: Children's Oncology Group )
AALL08P1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2009    Key Record Dates
Results First Posted: December 7, 2016
Last Update Posted: March 24, 2020
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisone
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Methotrexate
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Pegaspargase
Thioguanine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents