Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005585
Status:
COMPLETED
Last Update Posted:
2023-04-06
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 Treatment for Patients With Low Risk Acute Lymphoblastic Leukemia A Pediatric Oncology Group Phase III Study
Status:
COMPLETED
Status Verified Date:
2013-06
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 combination chemotherapy is more effective for childhood acute lymphoblastic leukemia
PURPOSE This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia
PURPOSE This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Compare the efficacy and toxicity of short methotrexate infusion vs longer infusion in patients with low-risk acute lymphoblastic leukemia
Compare the efficacy of these regimens of methotrexate with or without multidrug intensification in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to genetics stratum 1 trisomy 410 but not TELAML1 vs stratum 2 TELAML1 with or without trisomy 410
All patients receive induction therapy weeks 1-4 on another protocol POG-9900
Stratum 1
Consolidation therapy begins on week 5 Patients are randomized to arm I or II
Arm I Patients receive methotrexate MTX IV over 24 hours on day 1 and oral leucovorin calcium CF every 6 hours for 3 doses beginning 42 hours after initiation of MTX infusion during weeks 7 10 13 16 and 19
Arm II Patients receive MTX IV over 4 hours on day 1 and oral CF as in arm I during weeks 7 10 13 16 and 19
Patients in arms I and II also receive MTX intrathecally IT on weeks 7 10 13 16 19 and 22 oral mercaptopurine 6-MP daily on weeks 5-24 oral dexamethasone DM twice daily on days 1-7 of weeks 8 and 17 and vincristine VCR IV on day 1 of weeks 8 9 17 and 18
Stratum 2
Consolidation therapy begins on week 5 and delayed intensification therapy begins on week 16 Patients are randomized to delayed intensification or no delayed intensification Patients randomized to no delayed intensification are then randomized to consolidation therapy on arm I or II Patients randomized to delayed intensification are then randomized to arm III or IV Patients with trisomy 410 are not randomized to arms III and IV
Arm III Patients receive MTX IV and CF as in arm I on weeks 7 10 13 24 27 and 30
Arm IV Patients receive MTX IV and CF as in arm II on weeks 7 10 13 24 27 and 30
Patients in arms III and IV also receive oral 6-MP daily on weeks 5-13 and then beginning on week 24 and continuing until the end of consolidation MTX IT on weeks 7 10 13 16 20 21 and 30 oral DM twice daily on days 1-7 of weeks 8 16-18 and 28 VCR IV on day 1 of weeks 8 9 16-18 28 and 29 pegaspargase intramuscularly on week 16 daunorubicin IV on day 1 of weeks 16-18 cyclophosphamide IV on day 1 of week 20 cytarabine IV or subcutaneously on days 2-5 of weeks 20 and 21 and oral thioguanine daily on days 1-14 of weeks 20 and 21
All patients then receive continuation therapy beginning on week 25 for arms I and II and week 33 for arms III and IV and continuing until week 130 for all arms
Continuation
Arms I and II Patients receive oral 6-MP daily on weeks 25-130 oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 25 41 57 73 89 and 105 oral MTX weekly on weeks 25-130 except during weeks of IT MTX and MTX IT on weeks 25 37 49 61 73 85 97 and 109
Arms III and IV Patients receive oral 6-MP daily on weeks 33-130 oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 41 57 73 89 and 105 oral MTX weekly on weeks 33-130 except during weeks of IT MTX and MTX IT on weeks 37 49 61 73 85 97 and 109
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 902 patients will be accrued for this study within 322 years
Compare the efficacy and toxicity of short methotrexate infusion vs longer infusion in patients with low-risk acute lymphoblastic leukemia
Compare the efficacy of these regimens of methotrexate with or without multidrug intensification in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to genetics stratum 1 trisomy 410 but not TELAML1 vs stratum 2 TELAML1 with or without trisomy 410
All patients receive induction therapy weeks 1-4 on another protocol POG-9900
Stratum 1
Consolidation therapy begins on week 5 Patients are randomized to arm I or II
Arm I Patients receive methotrexate MTX IV over 24 hours on day 1 and oral leucovorin calcium CF every 6 hours for 3 doses beginning 42 hours after initiation of MTX infusion during weeks 7 10 13 16 and 19
Arm II Patients receive MTX IV over 4 hours on day 1 and oral CF as in arm I during weeks 7 10 13 16 and 19
Patients in arms I and II also receive MTX intrathecally IT on weeks 7 10 13 16 19 and 22 oral mercaptopurine 6-MP daily on weeks 5-24 oral dexamethasone DM twice daily on days 1-7 of weeks 8 and 17 and vincristine VCR IV on day 1 of weeks 8 9 17 and 18
Stratum 2
Consolidation therapy begins on week 5 and delayed intensification therapy begins on week 16 Patients are randomized to delayed intensification or no delayed intensification Patients randomized to no delayed intensification are then randomized to consolidation therapy on arm I or II Patients randomized to delayed intensification are then randomized to arm III or IV Patients with trisomy 410 are not randomized to arms III and IV
Arm III Patients receive MTX IV and CF as in arm I on weeks 7 10 13 24 27 and 30
Arm IV Patients receive MTX IV and CF as in arm II on weeks 7 10 13 24 27 and 30
Patients in arms III and IV also receive oral 6-MP daily on weeks 5-13 and then beginning on week 24 and continuing until the end of consolidation MTX IT on weeks 7 10 13 16 20 21 and 30 oral DM twice daily on days 1-7 of weeks 8 16-18 and 28 VCR IV on day 1 of weeks 8 9 16-18 28 and 29 pegaspargase intramuscularly on week 16 daunorubicin IV on day 1 of weeks 16-18 cyclophosphamide IV on day 1 of week 20 cytarabine IV or subcutaneously on days 2-5 of weeks 20 and 21 and oral thioguanine daily on days 1-14 of weeks 20 and 21
All patients then receive continuation therapy beginning on week 25 for arms I and II and week 33 for arms III and IV and continuing until week 130 for all arms
Continuation
Arms I and II Patients receive oral 6-MP daily on weeks 25-130 oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 25 41 57 73 89 and 105 oral MTX weekly on weeks 25-130 except during weeks of IT MTX and MTX IT on weeks 25 37 49 61 73 85 97 and 109
Arms III and IV Patients receive oral 6-MP daily on weeks 33-130 oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 41 57 73 89 and 105 oral MTX weekly on weeks 33-130 except during weeks of IT MTX and MTX IT on weeks 37 49 61 73 85 97 and 109
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 902 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-2012-02321 | OTHER | NCI | None |
| COG-P9904 | OTHER | None | None |
| POG-9904 | OTHER | None | None |
| CDR0000067657 | OTHER | None | None |