Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma

August 21, 2023 updated by: Biogen

Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma

The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.

To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites were activated. The study has subsequently closed to accrual. Currently 8 sites remain active to follow the 12 subjects enrolled in the past year.

Study Type

Interventional

Enrollment

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States
        • Loma Linda University
      • Oceanside, California, United States
        • North County Oncology
    • Connecticut
      • Fairfield, Connecticut, United States
        • Medical Specialists of Fairfield
    • Hawaii
      • Honolulu, Hawaii, United States
        • Queens Hospital
    • Illinois
      • Elk Grove Village, Illinois, United States
        • Northwest Oncology and Hematology
    • Indiana
      • Lafayette, Indiana, United States
        • Horizon Oncolgy Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Specialists in Hematology/Oncology
    • North Carolina
      • Charlotte, North Carolina, United States
        • Presbyterian Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Follicular non-Hodgkin's lymphoma including SLL in first or second relapse.
  • No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory.
  • Age >= 18 years, not pregnant or lactating.
  • Expected survival >= 3 mths; PS 0, 1, or 2.
  • ANC >= 1,500/mm3, platelet counts >= 100,000/mm3.
  • Total bilirubin > 2.0 mg/dL, creatinine > 2.0 mg/dL.
  • Total lymphocyte count < 5,000/mm3 for SLL.
  • <25% bone marrow involvement with lymphoma.

Exclusion Criteria:

  • Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection.
  • Bulky areas of disease more than 10 cm in diameter.
  • Patients with CLL, CNS, or mantle cell lymphoma.
  • Hx of HIV/AIDS related lymphoma, hepatitis B or C.
  • Prior radioimmunotherapy or XRT to >25% of active bone marrow.
  • G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy

Secondary Outcome Measures

Outcome Measure
Evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Wayne Saville, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2003

Study Completion (Actual)

October 31, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-03-ZEV
  • Former Biogen Idec: 106-I001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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