Clinical Trial: Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Abbreviated Fludarabine / Mitoxantrone / Rituximab Chemotherapy Followed by Zevalin for Relapsed Mantle Cell Lymphoma

Brief Summary:

  • 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.

Detailed Summary:

  • 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.

Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: 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 ]

Original Primary Outcome: 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.

Current Secondary Outcome:

  • To describe the progression-free survival [ Time Frame: TBD ]
  • 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 ]


Original Secondary Outcome:

  • To describe the progression-free survival
  • To determine the safety of FMR + Zevalin in these subjects
  • To determine the impact of Zevalin on minimal residual disease in subjects with relapsed mantle cell lymphoma


Information By: Dana-Farber Cancer Institute

Dates:
Date Received: July 7, 2005
Date Started: February 2005
Date Completion:
Last Updated: April 22, 2014
Last Verified: April 2014