Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002756
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
1999-11-01
Brief Title:
Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Induction Intensification in Infant ALL A Childrens Oncology Group 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 and giving them as induction intensification may kill more cancer cells
PURPOSE This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia
PURPOSE This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Assess the feasibility of intensification with two courses of high-dose methotrexate followed by one course of cyclophosphamideetoposide during induction and later as consolidation in infants with newly diagnosed acute lymphoblastic leukemia
Determine event-free survival after shortened intensive therapy in these patients
Compare event-free survival rates of infants receiving this regimen whose leukemic blasts have or do not have translocations involving the 11q23 gene MLL
Secondary
Correlate the presence of minimal residual disease at completion of induction beginning of continuation and at completion of therapy with patient outcome
Investigate the clinical prognostic features that may be associated with outcome in infants such as bone marrow blast content at day 8 white blood cell count and age
Correlate biologic characteristics of the leukemia cells at diagnosis protocol POG-9900 with outcome in patients treated with this regimen
Characterize patterns of gene expression associated with host and disease characteristics and treatment response in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to participating center and presence of CNS disease yes vs no
Patients receive induction chemotherapy comprising vincristine IV on days 1 8 and 15 oral prednisone three times a day on days 1-21 daunorubicin IV over 30 minutes on days 1-2 cyclophosphamide IV over 30 minutes every 12 hours on days 3-4 and asparaginase intramuscularly IM on days 4 6 8 10 12 15 17 and 19 Patients also receive triple intrathecal therapy comprising methotrexate hydrocortisone and cytarabine on days 1 8 and 15 and filgrastim G-CSF subcutaneously SC or IV beginning on day 5 and continuing until day 20 regardless of blood counts
Patients receive induction intensification chemotherapy comprising high-dose methotrexate IV over 24 hours triple intrathecal therapy as per induction therapy on days 22 and 29 and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses Patients also receive etoposide IV over 2 hours and cyclophosphamide IV over 30 minutes on days 36-40 Patients receive G-CSF SC or IV beginning on day 41 and continuing until blood counts recover
Patients achieving morphologic remission and recovery of blood counts while off G-CSF for 48 hours receive reinduction chemotherapy comprising the same regimen as in induction therapy with the exception of asparaginase IM beginning on day 1 week 8 and continuing every Monday Wednesday and Friday for a total of 8 doses and triple intrathecal therapy on days 1 and 15 only weeks 8 and 10 Patients receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover
After blood count recovery patients receive consolidation chemotherapy comprising triple intrathecal therapy as per induction therapy on day 1 week 11 high-dose methotrexate IV over 24 hours on weeks 8 and 12 and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses Patients also receive etoposide IV over 2 hours followed by cyclophosphamide IV over 30 minutes on days 15-19 week 13 Patients receive G-CSF SC or IV beginning on day 20 and continuing until blood counts recover On days 29-31 week 15 patients receive high-dose cytarabine IV over 3 hours every 12 hours for 4 doses and asparaginase IM 6 hours after completion of high-dose cytarabine Patients receive G-CSF beginning 24 hours after completion of asparaginase and continuing until blood counts recover
Patients achieving morphologic remission and blood count recovery while off G-CSF for 48 hours receive continuation therapy comprising vincristine IV on day 1 oral prednisone three times a day on days 1-5 and triple intrathecal therapy on day 1 weeks 18 and 22 Patients also receive methotrexate IM once a week and oral mercaptopurine daily on weeks 19-21 23 and 24 On week 25 patients receive etoposide IV over 2 hours daily followed by cyclophosphamide IV over 30 minutes daily on days 1-5 and G-CSF SC or IV beginning on day 6 and continuing until blood counts recover Patients receive an additional course of continuation therapy on weeks 28-35 On weeks 38-48 patients receive another identical course of continuation therapy with the exclusion of the etoposide and cyclophosphamide combination regimen
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 annually thereafter
PROJECTED ACCRUAL Approximately 58-104 patients will be accrued for this study within 21 years
Primary
Assess the feasibility of intensification with two courses of high-dose methotrexate followed by one course of cyclophosphamideetoposide during induction and later as consolidation in infants with newly diagnosed acute lymphoblastic leukemia
Determine event-free survival after shortened intensive therapy in these patients
Compare event-free survival rates of infants receiving this regimen whose leukemic blasts have or do not have translocations involving the 11q23 gene MLL
Secondary
Correlate the presence of minimal residual disease at completion of induction beginning of continuation and at completion of therapy with patient outcome
Investigate the clinical prognostic features that may be associated with outcome in infants such as bone marrow blast content at day 8 white blood cell count and age
Correlate biologic characteristics of the leukemia cells at diagnosis protocol POG-9900 with outcome in patients treated with this regimen
Characterize patterns of gene expression associated with host and disease characteristics and treatment response in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to participating center and presence of CNS disease yes vs no
Patients receive induction chemotherapy comprising vincristine IV on days 1 8 and 15 oral prednisone three times a day on days 1-21 daunorubicin IV over 30 minutes on days 1-2 cyclophosphamide IV over 30 minutes every 12 hours on days 3-4 and asparaginase intramuscularly IM on days 4 6 8 10 12 15 17 and 19 Patients also receive triple intrathecal therapy comprising methotrexate hydrocortisone and cytarabine on days 1 8 and 15 and filgrastim G-CSF subcutaneously SC or IV beginning on day 5 and continuing until day 20 regardless of blood counts
Patients receive induction intensification chemotherapy comprising high-dose methotrexate IV over 24 hours triple intrathecal therapy as per induction therapy on days 22 and 29 and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses Patients also receive etoposide IV over 2 hours and cyclophosphamide IV over 30 minutes on days 36-40 Patients receive G-CSF SC or IV beginning on day 41 and continuing until blood counts recover
Patients achieving morphologic remission and recovery of blood counts while off G-CSF for 48 hours receive reinduction chemotherapy comprising the same regimen as in induction therapy with the exception of asparaginase IM beginning on day 1 week 8 and continuing every Monday Wednesday and Friday for a total of 8 doses and triple intrathecal therapy on days 1 and 15 only weeks 8 and 10 Patients receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover
After blood count recovery patients receive consolidation chemotherapy comprising triple intrathecal therapy as per induction therapy on day 1 week 11 high-dose methotrexate IV over 24 hours on weeks 8 and 12 and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses Patients also receive etoposide IV over 2 hours followed by cyclophosphamide IV over 30 minutes on days 15-19 week 13 Patients receive G-CSF SC or IV beginning on day 20 and continuing until blood counts recover On days 29-31 week 15 patients receive high-dose cytarabine IV over 3 hours every 12 hours for 4 doses and asparaginase IM 6 hours after completion of high-dose cytarabine Patients receive G-CSF beginning 24 hours after completion of asparaginase and continuing until blood counts recover
Patients achieving morphologic remission and blood count recovery while off G-CSF for 48 hours receive continuation therapy comprising vincristine IV on day 1 oral prednisone three times a day on days 1-5 and triple intrathecal therapy on day 1 weeks 18 and 22 Patients also receive methotrexate IM once a week and oral mercaptopurine daily on weeks 19-21 23 and 24 On week 25 patients receive etoposide IV over 2 hours daily followed by cyclophosphamide IV over 30 minutes daily on days 1-5 and G-CSF SC or IV beginning on day 6 and continuing until blood counts recover Patients receive an additional course of continuation therapy on weeks 28-35 On weeks 38-48 patients receive another identical course of continuation therapy with the exclusion of the etoposide and cyclophosphamide combination regimen
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 annually thereafter
PROJECTED ACCRUAL Approximately 58-104 patients will be accrued for this study within 21 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 |
|---|---|---|---|
| CDR0000064693 | OTHER | Clinical Trialsgov | None |
| COG-P9407 | OTHER | None | None |
| POG-9407 | OTHER | None | None |