Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005603
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
ALinC 17 Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia ALL - Evaluation of the Augmented BFM Regimen A Phase III Study
Status:
COMPLETED
Status Verified Date:
2014-02
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 work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more cancer cells It is not yet known which combination chemotherapy regimen is more effective for acute lymphoblastic leukemia
PURPOSE Phase III trial to determine the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia
PURPOSE Phase III trial to determine the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Determine whether augmented BFM therapy is superior to ALinc 1415 therapy in patients with newly diagnosed high-risk acute lymphoblastic leukemia
Determine whether minimal residual disease after induction therapy is predictive of an inferior prognosis 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 Patients are stratified by CNS or testicular disease yes vs no
Induction therapy weeks 1-5 Patients receive oral prednisone 3 times daily on days 1-29 vincristine IV on days 1 8 15 and 22 daunorubicin IV on days 8 15 22 and asparaginase intramuscularly IM on days 2 5 8 12 15 and 19 Patients also receive methotrexate intrathecally IT on days 1 and 8 Patients with CNS 2 or 3 disease also receive methotrexate IT on days 15 and 22
Patients with M1 bone marrow proceed to consolidation therapy Patients achieving M2 bone marrow on day 29 receive oral prednisone 3 times daily on days 29-42 vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36 and asparaginase IM on days 29 32 36 and 39 If bone marrow is M3 on day 29 or M2 on day 43 then patient is off study
Consolidation therapy weeks 6-14 Patients receive cyclophosphamide IV over 30 minutes on days 1 and 29 cytarabine subcutaneously SC or IV on days 2-5 9-12 30-33 and 37-40 oral mercaptopurine daily on days 1-14 and 29-42 vincristine IV on days 15 22 43 and 50 asparaginase IM on days 15 17 19 22 24 26 43 45 47 50 52 and 54 and methotrexate IT on days 1 15 29 and 43
Patients then proceed to interim maintenance and delayed intensification on weeks 15-46 Courses repeat every 16 weeks
Maintenance I and II weeks 15-22 and 31-38 Patients receive vincristine IV and methotrexate IV on days 1 11 21 31 and 41 asparaginase IM on days 2 12 22 32 and 42 and methotrexate IT on days 1 and 31
Delayed Intensification weeks 23-36 and 39-42 Patients receive vincristine IV on days 57 64 and 71 methotrexate IT on day 57 oral dexamethasone 2-3 times daily on days 57-63 and 71-77 doxorubicin IV over 15 minutes 3 times weekly on days 57 64 and 71 and asparaginase IM on days 60 62 64 67 69 and 71
Delayed Intensification-Reconsolidation weeks 27-30 and 43-46 Patients receive oral thioguanine on days 85-98 methotrexate IT on day 85 cyclophosphamide IV over 30 minutes on day 85 cytarabine IV or SC on days 86-89 and 93-96 asparaginase IM on days 99 101 103 106 108 and 110 and vincristine IV on days 99 and 106
Continuation therapy weeks 47-130 Patients receive vincristine IV on days 1 29 and 57 oral dexamethasone twice daily for 5 consecutive days on days 1-5 29-33 and 57-61 oral mercaptopurine on days 1-84 oral methotrexate on days 8 15 22 29 36 43 50 57 64 71 and 78 and methotrexate IT on day 1
Patients with CNS 3 disease or who are within 24 months of diagnosis with an initial WBC 100000mm3 undergo whole brain radiotherapy omit or discontinue mercaptopurine and IT methotrexate on day 1 Testicular radiotherapy also begins on day 1
Patients may receive oral methotrexate on day 1 of each course if IT methotrexate is not administered
Patients are followed every 2 months for 2 years every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 260 patients will be accrued for this study within 31 years
Determine whether augmented BFM therapy is superior to ALinc 1415 therapy in patients with newly diagnosed high-risk acute lymphoblastic leukemia
Determine whether minimal residual disease after induction therapy is predictive of an inferior prognosis 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 Patients are stratified by CNS or testicular disease yes vs no
Induction therapy weeks 1-5 Patients receive oral prednisone 3 times daily on days 1-29 vincristine IV on days 1 8 15 and 22 daunorubicin IV on days 8 15 22 and asparaginase intramuscularly IM on days 2 5 8 12 15 and 19 Patients also receive methotrexate intrathecally IT on days 1 and 8 Patients with CNS 2 or 3 disease also receive methotrexate IT on days 15 and 22
Patients with M1 bone marrow proceed to consolidation therapy Patients achieving M2 bone marrow on day 29 receive oral prednisone 3 times daily on days 29-42 vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36 and asparaginase IM on days 29 32 36 and 39 If bone marrow is M3 on day 29 or M2 on day 43 then patient is off study
Consolidation therapy weeks 6-14 Patients receive cyclophosphamide IV over 30 minutes on days 1 and 29 cytarabine subcutaneously SC or IV on days 2-5 9-12 30-33 and 37-40 oral mercaptopurine daily on days 1-14 and 29-42 vincristine IV on days 15 22 43 and 50 asparaginase IM on days 15 17 19 22 24 26 43 45 47 50 52 and 54 and methotrexate IT on days 1 15 29 and 43
Patients then proceed to interim maintenance and delayed intensification on weeks 15-46 Courses repeat every 16 weeks
Maintenance I and II weeks 15-22 and 31-38 Patients receive vincristine IV and methotrexate IV on days 1 11 21 31 and 41 asparaginase IM on days 2 12 22 32 and 42 and methotrexate IT on days 1 and 31
Delayed Intensification weeks 23-36 and 39-42 Patients receive vincristine IV on days 57 64 and 71 methotrexate IT on day 57 oral dexamethasone 2-3 times daily on days 57-63 and 71-77 doxorubicin IV over 15 minutes 3 times weekly on days 57 64 and 71 and asparaginase IM on days 60 62 64 67 69 and 71
Delayed Intensification-Reconsolidation weeks 27-30 and 43-46 Patients receive oral thioguanine on days 85-98 methotrexate IT on day 85 cyclophosphamide IV over 30 minutes on day 85 cytarabine IV or SC on days 86-89 and 93-96 asparaginase IM on days 99 101 103 106 108 and 110 and vincristine IV on days 99 and 106
Continuation therapy weeks 47-130 Patients receive vincristine IV on days 1 29 and 57 oral dexamethasone twice daily for 5 consecutive days on days 1-5 29-33 and 57-61 oral mercaptopurine on days 1-84 oral methotrexate on days 8 15 22 29 36 43 50 57 64 71 and 78 and methotrexate IT on day 1
Patients with CNS 3 disease or who are within 24 months of diagnosis with an initial WBC 100000mm3 undergo whole brain radiotherapy omit or discontinue mercaptopurine and IT methotrexate on day 1 Testicular radiotherapy also begins on day 1
Patients may receive oral methotrexate on day 1 of each course if IT methotrexate is not administered
Patients are followed every 2 months for 2 years every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 260 patients will be accrued for this study within 31 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 |
|---|---|---|---|
| COG-P9906 | OTHER | None | None |
| POG-9906 | OTHER | None | None |
| CDR0000067722 | OTHER | ClinicalTrialsgov | None |