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Phase III Randomized Study of Multidrug Delayed-Intensification Therapy in Children With Newly Diagnosed Standard-Risk Acute Lymphocytic Leukemia: An ALinC #17 Study
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Related Information
Registry Information
Alternate Title
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Completed | 1 to 21 at diagnosis | COG-P9905
POG-9905, NCT00005596 |
Objectives - Determine if multidrug delayed-intensification therapy improves outcome in children with newly diagnosed standard-risk acute lymphocytic leukemia.
- Compare the efficacy and toxicity of methotrexate administered over 4 hours vs methotrexate administered over 24 hours in this patient population.
- Determine the correlation between event-free survival, minimal residual disease, and early response in this patient population treated with this multiple drug regimen.
Entry Criteria Disease Characteristics:
- Confirmed diagnosis of newly diagnosed B-precursor acute lymphocytic
leukemia
- Standard risk (not low, high, or very high risk)
- Prior registration and treatment on POG 9900 Classification Study
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: Other: - Not pregnant or nursing
- Fertile patients must use effective contraception
Expected Enrollment A total of 1,014 patients will be accrued for this study within 3.22 years. Outline This is a randomized, multicenter study. - Induction (weeks 1-4): Patients receive induction therapy on POG 9900.
- Consolidation (weeks 5-32): Patients are randomized to one of four treatment arms. Patients with t(1;19) are randomized to either arm III or arm
IV.
- Arm I (weeks 5-24): Patients receive IT methotrexate (MTX) on day 1 followed by MTX IV over 20 minutes followed by MTX
continuously over 23.6 hours on weeks 7, 10, 13, 16,19, and 22. At 42 hours
after the beginning of the MTX infusion, patients receive oral leucovorin
calcium every 6 hours for a total of 3 doses. Patients also receive oral
mercaptopurine daily beginning on week 5 and continuing until the completion
of consolidation therapy; oral dexamethasone twice daily on days 1-7 of weeks 8
and 17; and vincristine IV on day 1 of weeks 8, 9, 17, and 18.
- Arm II (weeks 5-24): Patients receive MTX IV over 4 hours on weeks 7,
10, 13, 16, 19, and 22. At 42 hours after the beginning of the MTX
infusion, patients receive oral leucovorin calcium as in arm I. Patients
also receive mercaptopurine, dexamethasone, vincristine, and IT MTX as in arm
I.
- Arm III (weeks 5-32): Patients receive MTX IV as in arm I on weeks 7,
10, 13, 24, 27, and 30; leucovorin calcium as in arm I; pegaspargase IM on
day 2, 3, OR 4 of week 16; and oral mercaptopurine daily on weeks
5-13, and from week 24 until the completion of consolidation therapy. Patients
also receive IT MTX as in arm I on weeks 7, 10, 13, 16, 20, 21, and 30; oral
dexamethasone twice daily on weeks 8, 16-18, and 28 for a total of 35 days;
vincristine IV on day 1 of weeks 8, 9, 16, 17, 18, 28, and 29; daunorubicin IV
on day 1 of weeks 16-18; cyclophosphamide IV over 30 minutes on day 1 of week
20; cytarabine IV or subcutaneously daily on days 2-5 of weeks 20 and 21; and
oral thioguanine daily on weeks 20-21.
- Arm IV (weeks 5-32): Patients receive MTX IV as in arm II on weeks 7,
10, 13, 24, 27, and 30; leucovorin calcium as in arm I; and pegaspargase,
mercaptopurine, IT MTX, dexamethasone, vincristine, daunorubicin,
cyclophosphamide, cytarabine, and thioguanine as in arm III.
- Intensive continuation (weeks 25-80): At weeks 25-72 for arms I and II, and at weeks 33-80 for arms III and
IV, patients receive oral MTX
every 6 hours for 4 doses on weeks 1, 3, 5, 7, 9, and 11; oral mercaptopurine
daily; oral leucovorin calcium every 12 hours for 2 doses beginning 48 hours
after the start of MTX; IT MTX and vincristine IV on day 1 of
week 12; and oral dexamethasone twice daily on days 1-7, beginning with the administration of vincristine. Treatment repeats every 12 weeks for 4 courses.
- Additional continuation (weeks 73-130): At weeks 73-130 for arms I and II, and at weeks 81-130 for arms III and
IV, patients receive oral MTX weekly; oral
mercaptopurine daily; vincristine IV on day 1 every 12 weeks; oral
dexamethasone as during intensive continuation therapy; and IT MTX on day 1
every 12 weeks, beginning with the last week of the first course (in place of oral MTX).
Patients are followed monthly for 1 year, every 2 months for 1 year,
every 3 months for 1 year, every 6 months for 1 year, and then every 6-12
months for 1 year. Related PublicationsBorowitz MJ, Devidas M, Hunger SP, et al.: Prognostic signficance of end consolidation minimal residual disease (MRD) in childhood acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group (COG). [Abstract] J Clin Oncol 26 (Suppl 15): A-10000, 2008. Borowitz MJ, Devidas M, Hunger SP, et al.: Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. Blood 111 (12): 5477-85, 2008.[PUBMED Abstract] Davies SM, Borowitz MJ, Rosner GL, et al.: Pharmacogenetics of minimal residual disease response in children with B-precursor acute lymphoblastic leukemia: a report from the Children's Oncology Group. Blood 111 (6): 2984-90, 2008.[PUBMED Abstract] Hinds PS, Hockenberry MJ, Gattuso JS, et al.: Dexamethasone alters sleep and fatigue in pediatric patients with acute lymphoblastic leukemia. Cancer 110 (10): 2321-30, 2007.[PUBMED Abstract] Winick N, Martin PL, Devidas M, et al.: Delayed intensification (DI) enhances event-free survival (EFS) of children with B-precursor acute lymphoblastic leukemia (ALL) who received intensification therapy with six courses of intravenous methotrexate (MTX): POG 9904/9905: a Children's Oncology Group study (COG). [Abstract] Blood 110 (11): A-583, 2007.
Trial Contact Information
Trial Lead Organizations Children's Oncology Group | | | | Naomi Winick, MD, Protocol chair | | | |
Related Information PDQ® clinical trial COG-ACCL01P3
| Registry Information | | | Official Title | | ALinC 17: Protocol for Patients with Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia (ALL): A Phase III Study | | | Trial Start Date | | 2000-04-07 | | | Trial Completion Date | | 2005-06-28 | | | Registered in ClinicalTrials.gov | | NCT00005596 | | | Date Submitted to PDQ | | 2000-02-29 | | | Information Last Verified | | 2005-06-28 | | | NCI Grant/Contract Number | | CA30969 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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