Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004228
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2000-01-28
Brief Title:
Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-11
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 It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma
PURPOSE This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma
PURPOSE This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma
Detailed Description:
OBJECTIVES
Compare the event-free survival and overall survival of children or adolescents with newly diagnosed disseminated stage III or IV lymphoblastic lymphoma treated with 4 chemotherapy regimens
Determine whether treatment with a regimen without methotrexate maintains the same disease-free survival as NHLBFM 90 in these patients
Determine whether intensification with anthracycline and cyclophosphamide improves disease-free survival in these patients
Collect outcome data on uniformly treated patients with localized disease or CNS-positive disease
Determine whether rapid reduction in tumor volume by chest radiography and CT scan is predictive of improved outcome in patients treated with these regimens
Determine the prevalence of bone marrow involvement at presentation in these patients
Determine whether peripheral blood can replace bone marrow in the initial staging of these patients
Determine the clinical significance of bone marrow and peripheral blood involvement in these patients
NOTE All patients as of 42006 receive treatment on Arm III regimen only
OUTLINE Patients are stratified by disease characteristics disseminated lymphoblastic lymphoma vs localized lymphoblastic lymphoma localized lymphoblastic lymphoma is closed to accrual as of 102005 and age Patients with CNS negative disseminated lymphoblastic lymphoma are randomized to 1 of 4 treatment arms Patients with testicular involvement at diagnosis are nonrandomly assigned to arm IV and do not receive testicular radiotherapy Patients with localized lymphoblastic lymphoma closed to accrual as of 102005 are not randomized
NOTE All patients as of 42006 receive treatment on Arm III only
Localized lymphoblastic lymphoma closed to accrual as of 102005
Induction 5 weeks Patients receive vincristine IV and daunorubicin IV over 15 minutes to 2 hours on days 0 7 14 and 21 oral prednisone on days 0-27 and asparaginase intramuscularly IM on days 3 5 and 7 and then 3 times a week for 9 doses during days 8-21 Patients also receive methotrexate intrathecally IT on days 7 and 28 and cytarabine IT on day 0
Consolidation 5 weeks Patients receive methotrexate IT on days 0 7 14 and 21 followed by cyclophosphamide IV over 1 hour on days 0 and 14 cytarabine IV on days 0-3 7-10 14-17 and 21-24 oral mercaptopurine on days 0-27 and oral prednisone over 10 days
Interim maintenance 8 weeks Patients receive methotrexate IT on days 0 and 28 oral mercaptopurine on days 0-41 and oral methotrexate on days 7 14 21 and 35
Delayed intensification 7 weeks Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0 7 and 14 asparaginase IM on day 3 and then 3 times a week for 6 doses oral dexamethasone on days 0-30 cyclophosphamide IV over 1 hour on day 28 and cytarabine IV or SC on days 28-31 and 35-38 Patients also receive oral thioguanine on days 28-41 and methotrexate IT on days 28 and 35
Maintenance 84 day course Patients receive vincristine IV on days 0 28 and 56 oral prednisone on days 0-4 28-32 and 56-60 oral methotrexate on days 7 14 21 28 35 42 49 56 63 70 and 77 oral mercaptopurine on days 0-83 and methotrexate IT on day 0
Disseminated lymphoblastic lymphoma
Arm I closed to accrual as of 42006 Patients receive same induction consolidation and interim maintenance therapy schedule as localized lymphoblastic lymphoma patients
Delayed intensification 7 weeks Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0 7 14 and 21 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-28 Patients also receive cyclophosphamide IV over 1 hour on day 35 cytarabine IV or SC on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Maintenance 84 day course Patients receive same therapy as localized lymphoblastic lymphoma patients except methotrexate IT is administered on day 0 and 28 for first 4 courses
Arm II closed to accrual as of 42006 Patients receive consolidation interim maintenance and maintenance therapy as in arm I
Induction 5 weeks Patients receive vincristine IV on days 0 7 14 and 21 daunorubicin IV over 48 hours on days 0-2 oral prednisone on days 0-27 and asparaginase IM on days 3 5 and 7 and then 3 times a week for 9 doses during days 8-21 Patients also receive methotrexate IT on days 7 and 28 cyclophosphamide IV over 1 hour on day 2 and cytarabine IT on day 0
Delayed intensification 7 weeks Patients receive vincristine IV on days 0 7 14 21 daunorubicin IV over 48 hours on days 0-2 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-28 Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35 cytarabine IV or SC on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Arm III
Induction 5 weeks Patients receive vincristine IV and daunorubicin IV over 1 hour on days 0 7 14 and 21 and oral prednisone on days 0-37 Patients also receive asparaginase IM on day 11 and then 3 times a week for 9 doses methotrexate IT on days 7 and 28 and cytarabine IT on day 0
Consolidation 5 weeks Patients receive methotrexate IT and cyclophosphamide IV over 1 hour on days 0 and 14 cytarabine IV or SC on days 0-3 7-10 14-17 and 21-24 oral mercaptopurine on days 0-27 and oral prednisone over 10 days
Interim maintenance 9 weeks Patients receive methotrexate IT and IV on days 7 21 35 and 49 oral mercaptopurine on days 0-55 and leucovorin calcium IV at 42 48 and 54 hours after methotrexate IV
Delayed intensification 10 weeks Patients receive vincristine IV and doxorubicin IV over 1 hour on days 0 7 14 and 21 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-29 Patients also receive cyclophosphamide IV over 1 hour on day 35 cytarabine IV on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Maintenance 84 day courses Patients receive vincristine IV on days 0 28 and 56 oral prednisone on days 0-4 28-32 and 56-60 oral methotrexate on days 7 14 21 28 35 42 49 56 63 70 and 77 and oral mercaptopurine on days 0-83
Arm IV closed to accrual as of 42006 Patients receive consolidation and interim maintenance therapy as in arm III
Induction Patients receive vincristine IV on days 0 7 14 and 21 daunorubicin IV over 48 hours on days 0-2 oral prednisone on days 0-37 asparaginase IM on day 11 and then 3 times a week for 9 doses methotrexate IT on days 7 14 21 and 28 cyclophosphamide IV on day 2 and cytarabine IT on day 0
Delayed intensification 10 weeks Patients receive vincristine IV on days 7 14 21 and 28 daunorubicin IV over 48 hours on days 0-2 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-29 Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35 cytarabine IV on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Maintenance 84 day courses Patients receive therapy as in arm III Patients who are over 1 year of age and have CNS disease at diagnosis undergo cranial radiotherapy once daily 5 days a week beginning on day 0 Patients over 2 years of age undergo radiotherapy over 11-14 days 6-9 days for 1-2 years of age
Patients are followed monthly for one year every 3 months for 1 year every 6 months for 15 years and then annually thereafter
PROJECTED ACCRUAL Approximately 250-400 patients will be accrued for this study within 5 years
Compare the event-free survival and overall survival of children or adolescents with newly diagnosed disseminated stage III or IV lymphoblastic lymphoma treated with 4 chemotherapy regimens
Determine whether treatment with a regimen without methotrexate maintains the same disease-free survival as NHLBFM 90 in these patients
Determine whether intensification with anthracycline and cyclophosphamide improves disease-free survival in these patients
Collect outcome data on uniformly treated patients with localized disease or CNS-positive disease
Determine whether rapid reduction in tumor volume by chest radiography and CT scan is predictive of improved outcome in patients treated with these regimens
Determine the prevalence of bone marrow involvement at presentation in these patients
Determine whether peripheral blood can replace bone marrow in the initial staging of these patients
Determine the clinical significance of bone marrow and peripheral blood involvement in these patients
NOTE All patients as of 42006 receive treatment on Arm III regimen only
OUTLINE Patients are stratified by disease characteristics disseminated lymphoblastic lymphoma vs localized lymphoblastic lymphoma localized lymphoblastic lymphoma is closed to accrual as of 102005 and age Patients with CNS negative disseminated lymphoblastic lymphoma are randomized to 1 of 4 treatment arms Patients with testicular involvement at diagnosis are nonrandomly assigned to arm IV and do not receive testicular radiotherapy Patients with localized lymphoblastic lymphoma closed to accrual as of 102005 are not randomized
NOTE All patients as of 42006 receive treatment on Arm III only
Localized lymphoblastic lymphoma closed to accrual as of 102005
Induction 5 weeks Patients receive vincristine IV and daunorubicin IV over 15 minutes to 2 hours on days 0 7 14 and 21 oral prednisone on days 0-27 and asparaginase intramuscularly IM on days 3 5 and 7 and then 3 times a week for 9 doses during days 8-21 Patients also receive methotrexate intrathecally IT on days 7 and 28 and cytarabine IT on day 0
Consolidation 5 weeks Patients receive methotrexate IT on days 0 7 14 and 21 followed by cyclophosphamide IV over 1 hour on days 0 and 14 cytarabine IV on days 0-3 7-10 14-17 and 21-24 oral mercaptopurine on days 0-27 and oral prednisone over 10 days
Interim maintenance 8 weeks Patients receive methotrexate IT on days 0 and 28 oral mercaptopurine on days 0-41 and oral methotrexate on days 7 14 21 and 35
Delayed intensification 7 weeks Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0 7 and 14 asparaginase IM on day 3 and then 3 times a week for 6 doses oral dexamethasone on days 0-30 cyclophosphamide IV over 1 hour on day 28 and cytarabine IV or SC on days 28-31 and 35-38 Patients also receive oral thioguanine on days 28-41 and methotrexate IT on days 28 and 35
Maintenance 84 day course Patients receive vincristine IV on days 0 28 and 56 oral prednisone on days 0-4 28-32 and 56-60 oral methotrexate on days 7 14 21 28 35 42 49 56 63 70 and 77 oral mercaptopurine on days 0-83 and methotrexate IT on day 0
Disseminated lymphoblastic lymphoma
Arm I closed to accrual as of 42006 Patients receive same induction consolidation and interim maintenance therapy schedule as localized lymphoblastic lymphoma patients
Delayed intensification 7 weeks Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0 7 14 and 21 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-28 Patients also receive cyclophosphamide IV over 1 hour on day 35 cytarabine IV or SC on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Maintenance 84 day course Patients receive same therapy as localized lymphoblastic lymphoma patients except methotrexate IT is administered on day 0 and 28 for first 4 courses
Arm II closed to accrual as of 42006 Patients receive consolidation interim maintenance and maintenance therapy as in arm I
Induction 5 weeks Patients receive vincristine IV on days 0 7 14 and 21 daunorubicin IV over 48 hours on days 0-2 oral prednisone on days 0-27 and asparaginase IM on days 3 5 and 7 and then 3 times a week for 9 doses during days 8-21 Patients also receive methotrexate IT on days 7 and 28 cyclophosphamide IV over 1 hour on day 2 and cytarabine IT on day 0
Delayed intensification 7 weeks Patients receive vincristine IV on days 0 7 14 21 daunorubicin IV over 48 hours on days 0-2 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-28 Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35 cytarabine IV or SC on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Arm III
Induction 5 weeks Patients receive vincristine IV and daunorubicin IV over 1 hour on days 0 7 14 and 21 and oral prednisone on days 0-37 Patients also receive asparaginase IM on day 11 and then 3 times a week for 9 doses methotrexate IT on days 7 and 28 and cytarabine IT on day 0
Consolidation 5 weeks Patients receive methotrexate IT and cyclophosphamide IV over 1 hour on days 0 and 14 cytarabine IV or SC on days 0-3 7-10 14-17 and 21-24 oral mercaptopurine on days 0-27 and oral prednisone over 10 days
Interim maintenance 9 weeks Patients receive methotrexate IT and IV on days 7 21 35 and 49 oral mercaptopurine on days 0-55 and leucovorin calcium IV at 42 48 and 54 hours after methotrexate IV
Delayed intensification 10 weeks Patients receive vincristine IV and doxorubicin IV over 1 hour on days 0 7 14 and 21 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-29 Patients also receive cyclophosphamide IV over 1 hour on day 35 cytarabine IV on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Maintenance 84 day courses Patients receive vincristine IV on days 0 28 and 56 oral prednisone on days 0-4 28-32 and 56-60 oral methotrexate on days 7 14 21 28 35 42 49 56 63 70 and 77 and oral mercaptopurine on days 0-83
Arm IV closed to accrual as of 42006 Patients receive consolidation and interim maintenance therapy as in arm III
Induction Patients receive vincristine IV on days 0 7 14 and 21 daunorubicin IV over 48 hours on days 0-2 oral prednisone on days 0-37 asparaginase IM on day 11 and then 3 times a week for 9 doses methotrexate IT on days 7 14 21 and 28 cyclophosphamide IV on day 2 and cytarabine IT on day 0
Delayed intensification 10 weeks Patients receive vincristine IV on days 7 14 21 and 28 daunorubicin IV over 48 hours on days 0-2 asparaginase IM on day 3 and then 3 times a week for 6 doses and oral dexamethasone on days 0-29 Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35 cytarabine IV on days 35-38 and 42-45 oral thioguanine on days 35-48 and methotrexate IT on days 35 and 42
Maintenance 84 day courses Patients receive therapy as in arm III Patients who are over 1 year of age and have CNS disease at diagnosis undergo cranial radiotherapy once daily 5 days a week beginning on day 0 Patients over 2 years of age undergo radiotherapy over 11-14 days 6-9 days for 1-2 years of age
Patients are followed monthly for one year every 3 months for 1 year every 6 months for 15 years and then annually thereafter
PROJECTED ACCRUAL Approximately 250-400 patients will be accrued for this study within 5 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 |
|---|---|---|---|
| CDR0000067470 | OTHER | Clinical Trialsgov | None |
| CCG-59701 | OTHER | None | None |
| CCG-59701C | OTHER | None | None |
| CCG-A5971 | OTHER | None | None |
| POG-A5971 | OTHER | None | None |