Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039195
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2002-06-06
Brief Title:
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-06
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy total-body irradiation and peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab total-body irradiation and peripheral stem cell transplant works in treating patients with lymphoma
PURPOSE This phase II trial is studying how well giving chemotherapy with rituximab followed by combination chemotherapy with or without rituximab total-body irradiation and peripheral stem cell transplant works in treating patients with lymphoma
Detailed Description:
OUTLINE Patients are stratified according to risk low-intermediate vs high-intermediate or high
Patients receive induction chemotherapy comprising cyclophosphamide IV doxorubicin IV over 15 minutes and vincristine IV over 1-2 minutes on day 1 oral prednisone once daily on days 1-5 and filgrastim G-CSF subcutaneously SC once daily on days 7-11 or PEG-filgrastim once at least 24 hours after infusion Patients also receive rituximab IV 2-3 days apart for a total of 2 doses during the week prior to the first course of chemotherapy and on day 1 of courses 2-4 of chemotherapy Treatment repeats every 14 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
After the completion of induction chemotherapy patients undergo CT scan and positron emission tomography PET scanning If the PET scan is positive in one or more nodal sites a repeat biopsy is performed Patients with a negative PET scan OR a negative repeat biopsy including no evidence of lymphoma on repeat bone marrow biopsy are assigned to receive regimen A for consolidation therapy Patients with a positive repeat biopsy are assigned to receive regimen B for consolidation therapy
Regimen A Patients receive consolidation chemotherapy comprising etoposide IV over 1 hour on days 1-3 ifosfamide IV continuously over 24 hours on day 2 carboplatin IV on day 2 and G-CSF SC once daily on days 5-12 or PEG-filgrastim once at least 24 hours after infusion Treatment repeats every 14 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Regimen B Patients receive consolidation chemotherapy as in regimen A for 3 courses Patients also receive rituximab IV on days -3 to -1 of course 3 of chemotherapy Patients undergo leukapheresis at the completion of course 3 G-CSF continues from day 5 until the end of leukapheresis After completion of leukapheresis patients begin a regimen of high-dose chemoradiotherapy comprising either total body irradiation twice daily on days -10 to -7 and ifosfamide IV over 1 hour and etoposide IV continuously on days -6 to -2 or BEAM chemotherapy comprising carmustine etoposide cytarabine and melphalan Autologous peripheral blood stem cells APBSC are reinfused on day 0 Patients also receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover Beginning on day 42 post-APBSC if blood counts have recovered patients receive rituximab IV once weekly for 4 weeks Rituximab is repeated beginning on day 180 in the absence of disease progression
Patients who receive consolidation therapy on regimen A are followed at 4-6 weeks after chemotherapy and patients who receive consolidation therapy on regimen B are followed at 90-120 days after transplantation All patients are followed closely for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 40-98 patients will be accrued for this study within 4 years
Patients receive induction chemotherapy comprising cyclophosphamide IV doxorubicin IV over 15 minutes and vincristine IV over 1-2 minutes on day 1 oral prednisone once daily on days 1-5 and filgrastim G-CSF subcutaneously SC once daily on days 7-11 or PEG-filgrastim once at least 24 hours after infusion Patients also receive rituximab IV 2-3 days apart for a total of 2 doses during the week prior to the first course of chemotherapy and on day 1 of courses 2-4 of chemotherapy Treatment repeats every 14 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
After the completion of induction chemotherapy patients undergo CT scan and positron emission tomography PET scanning If the PET scan is positive in one or more nodal sites a repeat biopsy is performed Patients with a negative PET scan OR a negative repeat biopsy including no evidence of lymphoma on repeat bone marrow biopsy are assigned to receive regimen A for consolidation therapy Patients with a positive repeat biopsy are assigned to receive regimen B for consolidation therapy
Regimen A Patients receive consolidation chemotherapy comprising etoposide IV over 1 hour on days 1-3 ifosfamide IV continuously over 24 hours on day 2 carboplatin IV on day 2 and G-CSF SC once daily on days 5-12 or PEG-filgrastim once at least 24 hours after infusion Treatment repeats every 14 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Regimen B Patients receive consolidation chemotherapy as in regimen A for 3 courses Patients also receive rituximab IV on days -3 to -1 of course 3 of chemotherapy Patients undergo leukapheresis at the completion of course 3 G-CSF continues from day 5 until the end of leukapheresis After completion of leukapheresis patients begin a regimen of high-dose chemoradiotherapy comprising either total body irradiation twice daily on days -10 to -7 and ifosfamide IV over 1 hour and etoposide IV continuously on days -6 to -2 or BEAM chemotherapy comprising carmustine etoposide cytarabine and melphalan Autologous peripheral blood stem cells APBSC are reinfused on day 0 Patients also receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover Beginning on day 42 post-APBSC if blood counts have recovered patients receive rituximab IV once weekly for 4 weeks Rituximab is repeated beginning on day 180 in the absence of disease progression
Patients who receive consolidation therapy on regimen A are followed at 4-6 weeks after chemotherapy and patients who receive consolidation therapy on regimen B are followed at 90-120 days after transplantation All patients are followed closely for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 40-98 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| MSKCC-01142 | None | None | None |
| NCI-G02-2069 | None | None | None |