Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
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| ClinicalTrials.gov Identifier: NCT00866307 |
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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
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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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 |
Show detailed description
| 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Pegaspargase
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: pegaspargase
Given IV
Other Names:
Drug: cytarabine Given IT and IV or SC
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: prednisone Given IV or PO
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: methotrexate Given IT and PO
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: mercaptopurine Given PO
Other Names:
Drug: thioguanine Given PO
Other Name: 6-TG Radiation: prophylactic cranial irradiation Undergo radiation
Other Name: PCI Other: laboratory biomarker analysis Correlative studies |
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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.
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Drug: pegaspargase
Given IV
Other Names:
Drug: cytarabine Given IT and IV or SC
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Drug: doxorubicin hydrochloride Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Drug: prednisone Given IV or PO
Other Names:
Drug: dexamethasone Given IV
Other Names:
Drug: methotrexate Given IT and PO
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: mercaptopurine Given PO
Other Names:
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 :
- 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.
- 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)
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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 20 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | ZoAnn Dreyer, MD | Children's Oncology Group |
| 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:
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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 |