Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002665
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
1999-11-01
Brief Title:
SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE WITH OR WITHOUT PIXY IN PREVIOUSLY UNTREATED PATIENTS FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FIRST COMPLETE REMISSION
Status:
COMPLETED
Status Verified Date:
2015-03
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 chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with or without bone marrow transplantation in treating patients who have acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with or without bone marrow transplantation in treating patients who have acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Evaluate if front line induction therapy with daunorubicin vincristine prednisone and asparaginase is sufficiently effective to warrant a phase III trial in patients with acute lymphocytic leukemia ALL II Assess the toxicity of this regimen in this patient population III Assess disease free and overall survival and toxicity associated with allogeneic bone marrow transplantation for ALL patients in first remission following induction and consolidation therapy IV Assess disease free and overall survival and toxicity associated with sequential regimens of mercaptopurine methotrexate and vincristine doxorubicin dexamethasone and cyclophosphamide thioguanine and cytarabine in ALL patients in first remission who are ineligible for allogeneic bone marrow transplantation V Evaluate the prognostic significance of cell surface immunophenotype Philadelphia chromosome and polymerase chain reaction detected BCRabl fusion in this patient population
OUTLINE Patients are stratified according to age 15 to 29 vs 30 to 49 vs 50 to 65 performance status 0-1 vs 2-3 participating center and candidate for allogeneic bone marrow transplantation yes vs no Patients receive induction chemotherapy consisting of daunorubicin IV on days 1-3 vincristine IV on days 1 8 15 and 22 oral prednisone on days 1-28 and asparaginase IV or intramuscularly IM on days 15-24 Patients with persistent leukemia on day 21 receive additional induction therapy consisting of daunorubicin IV on days 22 and 23 vincristine IV on days 29 and 36 and oral prednisone continuing to day 42 Patients with CNS leukemia receive additional therapy beginning on day 1 of induction chemotherapy consisting of methotrexate intrathecally IT or intraventricularly twice weekly until blasts are absent in spinal fluid Patients receive oral leucovorin calcium every 6 hours for a total of 4 doses following each IT dose in the absence of blood count recovery Following absence of spinal fluid blasts patients receive methotrexate IT or intraventricularly weekly for 4 weeks then monthly for 1 year Patients also receive cranial radiotherapy during consolidation therapy 5 days a week for 25 weeks Patients with A1 bone marrow receive consolidation therapy following completion of induction therapy and blood count recovery Patients receive consolidation therapy consisting of cyclophosphamide IV on days 1 15 and 29 cytarabine IV on days 2-5 9-12 16-19 and 23-26 oral mercaptopurine on days 1-28 and methotrexate IT on days 2 9 16 and 23 Following completion of consolidation therapy patients eligible for allogeneic bone marrow transplantation receive total body radiotherapy 3 times a day on days -7 -6 -5 and twice on day -4 and eptoposide IV over 4 hours on day -3 Patients undergo allogeneic bone marrow transplantation on day 0 Following completion of consolidation therapy patients ineligible for allogeneic bone marrow transplantation receive maintenance therapy consisting of oral mercaptopurine on days 1-63 and oral methotrexate on days 1 8 15 22 29 36 43 50 and 57 Patients receive subsequent courses of maintenance therapy when blood counts recover Patients receive a second course of maintenance therapy consisting of vincristine IV on days 1 8 15 and 22 doxorubicin IV on days 1 8 15 and 22 and oral dexamethasone on days 1-28 Patients receive a third course consisting of cyclophosphamide IV on day 1 oral thioguanine on days 1-14 and cytarabine IV on days 3-6 and 10-13 Patients receive a fourth course consisting of oral mercaptopurine and oral methotrexate daily for 2 years Patients are followed monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study
OUTLINE Patients are stratified according to age 15 to 29 vs 30 to 49 vs 50 to 65 performance status 0-1 vs 2-3 participating center and candidate for allogeneic bone marrow transplantation yes vs no Patients receive induction chemotherapy consisting of daunorubicin IV on days 1-3 vincristine IV on days 1 8 15 and 22 oral prednisone on days 1-28 and asparaginase IV or intramuscularly IM on days 15-24 Patients with persistent leukemia on day 21 receive additional induction therapy consisting of daunorubicin IV on days 22 and 23 vincristine IV on days 29 and 36 and oral prednisone continuing to day 42 Patients with CNS leukemia receive additional therapy beginning on day 1 of induction chemotherapy consisting of methotrexate intrathecally IT or intraventricularly twice weekly until blasts are absent in spinal fluid Patients receive oral leucovorin calcium every 6 hours for a total of 4 doses following each IT dose in the absence of blood count recovery Following absence of spinal fluid blasts patients receive methotrexate IT or intraventricularly weekly for 4 weeks then monthly for 1 year Patients also receive cranial radiotherapy during consolidation therapy 5 days a week for 25 weeks Patients with A1 bone marrow receive consolidation therapy following completion of induction therapy and blood count recovery Patients receive consolidation therapy consisting of cyclophosphamide IV on days 1 15 and 29 cytarabine IV on days 2-5 9-12 16-19 and 23-26 oral mercaptopurine on days 1-28 and methotrexate IT on days 2 9 16 and 23 Following completion of consolidation therapy patients eligible for allogeneic bone marrow transplantation receive total body radiotherapy 3 times a day on days -7 -6 -5 and twice on day -4 and eptoposide IV over 4 hours on day -3 Patients undergo allogeneic bone marrow transplantation on day 0 Following completion of consolidation therapy patients ineligible for allogeneic bone marrow transplantation receive maintenance therapy consisting of oral mercaptopurine on days 1-63 and oral methotrexate on days 1 8 15 22 29 36 43 50 and 57 Patients receive subsequent courses of maintenance therapy when blood counts recover Patients receive a second course of maintenance therapy consisting of vincristine IV on days 1 8 15 and 22 doxorubicin IV on days 1 8 15 and 22 and oral dexamethasone on days 1-28 Patients receive a third course consisting of cyclophosphamide IV on day 1 oral thioguanine on days 1-14 and cytarabine IV on days 3-6 and 10-13 Patients receive a fourth course consisting of oral mercaptopurine and oral methotrexate daily for 2 years Patients are followed monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-9400 | OTHER | None | None |