Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005596
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
ALinC 17 Protocol for Patients With Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia ALL A Phase III Study
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells It is not yet known which regimen of chemotherapy is more effective for acute lymphoblastic leukemia
PURPOSE This randomized phase III trial is comparing four regimens of combination chemotherapy to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia
PURPOSE This randomized phase III trial is comparing four regimens of combination chemotherapy to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia
Detailed Description:
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
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 t119 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 236 hours on weeks 7 10 13 1619 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
PROJECTED ACCRUAL A total of 1014 patients will be accrued for this study within 322 years
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
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 t119 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 236 hours on weeks 7 10 13 1619 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
PROJECTED ACCRUAL A total of 1014 patients will be accrued for this study within 322 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02325 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| COG-P9905 | OTHER | None | None |
| POG-9905 | OTHER | None | None |
| CDR0000067704 | OTHER | None | None |