Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00119730|
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : April 24, 2014
- The purpose of this study is to find out whether combining a short course of chemotherapy (Fludarabine, Mitoxantrone and Rituximab) followed by Zevalin will be effective in treating relapsed mantle cell lymphoma.
- The secondary purposes of the study are to determine the safety and to evaluate whether there is additional benefit from Zevalin therapy following the chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Fludarabine Drug: Mitoxantrone Drug: Rituximab Drug: Zevalin||Phase 2|
- Patients receive fludarabine (days 1-3), mitoxantrone (day 1), and rituximab (day 1) of each 28-day cycle.
- Patients undergo a CT scan and bone marrow biopsy after two cycles. Unless the cancer has progressed, the patient will then receive Zevalin study treatment.
- Blood counts are taken every week for 12 weeks. After 12 weeks, a CT scan and bone marrow biopsy are performed.
- Long-term followup is 4 years. Physical exam and blood work is performed every 3 months for the first two years. Following that, physical exams and blood work is every 6 months for another two years. CT scans and bone marrow biopsies are every 6 months during this 4 year followup period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abbreviated Fludarabine / Mitoxantrone / Rituximab Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2013|
Experimental: Fludarabine, Mitoxantrone, Rituximab, Zevalin
Drug: Fludarabine Given on days 1-3 of each 28-day cycle Drug: Mitoxantrone Given on day 1 of each 28-day cycle Drug: Rituximab Given on day 1 of each 28-day cycle Drug: Zevalin Given after two cycles if there is no disease progression.
Given on days 1-3 of each 28-day cycle
Other Name: Fludara
Given on day 1 of each 28-day cycle
Other Name: Mitozantrone
Given on day 1 of each 28-day cycle
Other Name: Rituxan, MabThera and Zytux
After two cycles if there is no disease progression, zevalin treatment will be given. Rituximab will be given followed by an imaging dose of zevalin. Two or three scans will be performed over a week to determine if it is safe to give the full treatment dose of zevalin. The treatment dose is given with the second infusion or rituximab, seven days after the first dose.
Other Name: Ibritumomab tiuxetan
- The primary objective is to determine the response rate to two cycles of FMR + Zevalin in patients with relapsed mantle cell lymphoma, using a two-stage design. [ Time Frame: 2 years ]
- To describe the progression-free survival
- To determine the safety of FMR + Zevalin in these subjects [ Time Frame: 2 years ]
- To determine the impact of Zevalin on minimal residual disease in subjects with relapsed mantle cell lymphoma [ Time Frame: 2 years ]
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): NCT00119730
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jennifer R Brown, MD, PhD||Dana-Farber Cancer Institute|