Rituximab, Fludarabine, Cyclophosphamide, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00397800|
Recruitment Status : Unknown
Verified August 2012 by Technische Universität München.
Recruitment status was: Active, not recruiting
First Posted : November 10, 2006
Last Update Posted : August 28, 2012
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 I/II 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-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate Radiation: yttrium Y 90 ibritumomab tiuxetan||Phase 1 Phase 2|
- 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-Hodgkin's lymphoma.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Masking:||None (Open Label)|
|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 I/II Study for Treatment of Patients With Relapsed Indolent and Transformed CD20-Positive B-Cell Non-Hodgkin's-Lymphoma Ineligible for High-Dose Chemo(Radio)Therapy Supported by Autologous Peripheral Blood Stem-Cells|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||May 2008|
|Estimated Study Completion Date :||May 2013|
- Dose-limiting toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397800
|Medizinische Klinik, Klinikum Augsburg|
|Augsburg, Germany, D-86156|
|Medizinische Klinik III - Universitaetsklinikum Erlangen|
|Erlangen, Germany, D-91054|
|Goettingen, Germany, D-37075|
|Universitaetsklinikum Schleswig-Holstein - Campus Luebeck|
|Luebeck, Germany, D-23538|
|Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg|
|Magdeburg, Germany, D-39120|
|Mainz, Germany, D-55101|
|Munich, Germany, D-81366|
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Klinikum der Universitaet Regensburg|
|Regensburg, Germany, D-93042|
|Tuebingen, Germany, D-72076|
|Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm|
|Ulm, Germany, D-89081|
|Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg|
|Wuerzburg, Germany, D-97080|
|Study Chair:||Christian Peschel, MD||Technische Universität München|