Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397800
Status:
UNKNOWN
Last Update Posted:
2012-08-28
First Post:
2006-11-09
Brief Title:
Rituximab Fludarabine Cyclophosphamide and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed B-Cell Non-Hodgkins Lymphoma
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Safety and Efficacy of Sequential Treatment With a Combination of Rituximab Fludarabine and Cyclophosphamide Followed by Zevalin Rituximab and Y-Ibritumomab Tiuxetan - A Phase III Study for Treatment of Patients With Relapsed Indolent and Transformed CD20-Positive B-Cell Non-Hodgkins-Lymphoma Ineligible for High-Dose ChemoRadioTherapy Supported by Autologous Peripheral Blood Stem-Cells
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy such as fludarabine and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Radiolabeled monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan can find cancer cells and carry cancer-killing substances to them without harming normal cells Giving rituximab and chemotherapy together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab fludarabine and cyclophosphamide and to see how well they work in treating patients with relapsed B-cell non-Hodgkins lymphoma
PURPOSE This phase III trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab fludarabine and cyclophosphamide and to see how well they work in treating patients with relapsed B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of rituximab and yttrium Y 90 90Y ibritumomab tiuxetan when administered with rituximab as radioimmunotherapy after rituximab fludarabine and cyclophosphamide in patients with relapsed indolent mantle cell or transformed CD20-positive B-cell non-Hodgkins lymphoma
Secondary
Determine the overall survival in patients treated with this regimen
Determine time to progression and event-free survival in patients treated with this regimen
Determine partial and complete response rates in patients treated with this regimen
Determine time to maximal response in patients treated with this regimen
Determine response duration in patients treated with this regimen
Determine the feasibility of additional antineoplastic treatment following disease relapse after treatment with rituximab and 90Y ibritumomab tiuxetan in these patients
OUTLINE This is a prospective nonrandomized multicenter phase I dose-escalation study of yttrium Y 90 90Y ibritumomab tiuxetan followed by a phase II open-label study
Phase I
Chemoimmunotherapy Patients receive rituximab IV on day 1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-3 Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression Four weeks after the first day of the last chemoimmunotherapy course patients receive 1 dose of rituximab IV alone Patients with disease progression are removed from the study Patients with stable disease proceed to radioimmunotherapy 8-12 weeks after the first day of the last chemoimmunotherapy course
Radioimmunotherapy Patients receive rituximab IV and an imaging dose of indium In III ibritumomab tiuxetan IV over 10 minutes on day 1 Patients then undergo imaging If dosimetry is acceptable patients receive rituximab IV and 90Y ibritumomab tiuxetan IV over 10 minutes on day 8
Cohorts of 3-6 patients receive escalating doses of 90Y ibritumomab tiuxetan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive chemoimmunotherapy and radioimmunotherapy as in phase I at the MTD determined in phase I
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of rituximab and yttrium Y 90 90Y ibritumomab tiuxetan when administered with rituximab as radioimmunotherapy after rituximab fludarabine and cyclophosphamide in patients with relapsed indolent mantle cell or transformed CD20-positive B-cell non-Hodgkins lymphoma
Secondary
Determine the overall survival in patients treated with this regimen
Determine time to progression and event-free survival in patients treated with this regimen
Determine partial and complete response rates in patients treated with this regimen
Determine time to maximal response in patients treated with this regimen
Determine response duration in patients treated with this regimen
Determine the feasibility of additional antineoplastic treatment following disease relapse after treatment with rituximab and 90Y ibritumomab tiuxetan in these patients
OUTLINE This is a prospective nonrandomized multicenter phase I dose-escalation study of yttrium Y 90 90Y ibritumomab tiuxetan followed by a phase II open-label study
Phase I
Chemoimmunotherapy Patients receive rituximab IV on day 1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-3 Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression Four weeks after the first day of the last chemoimmunotherapy course patients receive 1 dose of rituximab IV alone Patients with disease progression are removed from the study Patients with stable disease proceed to radioimmunotherapy 8-12 weeks after the first day of the last chemoimmunotherapy course
Radioimmunotherapy Patients receive rituximab IV and an imaging dose of indium In III ibritumomab tiuxetan IV over 10 minutes on day 1 Patients then undergo imaging If dosimetry is acceptable patients receive rituximab IV and 90Y ibritumomab tiuxetan IV over 10 minutes on day 8
Cohorts of 3-6 patients receive escalating doses of 90Y ibritumomab tiuxetan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive chemoimmunotherapy and radioimmunotherapy as in phase I at the MTD determined in phase I
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 12 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 |
|---|---|---|---|
| EU-20633 | None | None | None |
| KRDI-TUM-R-F-015-V-0030-I | None | None | None |