Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058422
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2003-04-07
Brief Title:
Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of R-CHOP and Ibritumomab Tiuxetan Zevalin for Elderly Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2020-10
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 Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have B-cell lymphoma that has not been previously treated
PURPOSE Phase II trial to study the effectiveness of combining rituximab and combination chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have B-cell lymphoma that has not been previously treated
Detailed Description:
OBJECTIVES
Determine the progression-free and overall survival of patients age 60 and over with previously untreated diffuse large B-cell lymphoma treated with rituximab cyclophosphamide doxorubicin vincristine and prednisone R-CHOP combined with yttrium Y 90 ibritumomab tiuxetan
Determine the incidence of adverse experiences hematologic toxicity WBC hemoglobin and platelet nadirs and transfusion requirements cardiac toxicity incidence of left ventricular dysfunction and cardiomyopathy by echocardiography and the development of human antimouse antibodyhuman anti-chimeric antibody in patients treated with this regimen
Determine the predictive value of detecting minimal residual disease by molecular techniques for future relapserecurrence in patients treated with this regimen
Determine the response rate of patients treated with this regimen
Determine the red blood cell transfusion requirements change in hemoglobin from baseline and incidence of anemia with prophylactic darbepoetin alfa support in patients treated with this regimen
Determine the conversion rate to complete remission in patients treated with ibritumomab tiuxetan who achieve a partial remission post-R-CHOP
Determine the effect of darbepoetin alfa on the quality of life of these patients
OUTLINE This is an open-label nonrandomized study
Chemotherapy Patients receive rituximab IV over 2-5 hours cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 oral prednisone on days 1-5 or 2-6 and filgrastim G-CSF subcutaneously SC on days 7-15 Patients also receive darbepoetin alfa SC on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Radioimmunotherapy Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan IDEC-In2B8 IV over 10 minutes on day 0
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan If the flow is deemed safe then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7
Quality of life is assessed at baseline before course 5 of chemotherapy before radioimmunotherapy and at 3 months
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study
Determine the progression-free and overall survival of patients age 60 and over with previously untreated diffuse large B-cell lymphoma treated with rituximab cyclophosphamide doxorubicin vincristine and prednisone R-CHOP combined with yttrium Y 90 ibritumomab tiuxetan
Determine the incidence of adverse experiences hematologic toxicity WBC hemoglobin and platelet nadirs and transfusion requirements cardiac toxicity incidence of left ventricular dysfunction and cardiomyopathy by echocardiography and the development of human antimouse antibodyhuman anti-chimeric antibody in patients treated with this regimen
Determine the predictive value of detecting minimal residual disease by molecular techniques for future relapserecurrence in patients treated with this regimen
Determine the response rate of patients treated with this regimen
Determine the red blood cell transfusion requirements change in hemoglobin from baseline and incidence of anemia with prophylactic darbepoetin alfa support in patients treated with this regimen
Determine the conversion rate to complete remission in patients treated with ibritumomab tiuxetan who achieve a partial remission post-R-CHOP
Determine the effect of darbepoetin alfa on the quality of life of these patients
OUTLINE This is an open-label nonrandomized study
Chemotherapy Patients receive rituximab IV over 2-5 hours cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 oral prednisone on days 1-5 or 2-6 and filgrastim G-CSF subcutaneously SC on days 7-15 Patients also receive darbepoetin alfa SC on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Radioimmunotherapy Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan IDEC-In2B8 IV over 10 minutes on day 0
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan If the flow is deemed safe then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7
Quality of life is assessed at baseline before course 5 of chemotherapy before radioimmunotherapy and at 3 months
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 65 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 |
|---|---|---|---|
| MSKCC-02090 | None | None | None |