ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma

This study has been completed.

Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00168727
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Lymphoma, Low-Grade
Drug: ibritumomab tiuxetan (Zevalin®)
Phase IV

MedlinePlus related topics:   Lymphoma   

ChemIDplus related topics:   Rituximab    Ibritumomab tiuxetan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment:   12
Study Start Date:   June 2003
Estimated Study Completion Date:   October 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168727

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

Sponsors and Collaborators
Biogen Idec

Investigators
Study Director:     Wayne Saville     Biogen Idec    
  More Information


Study ID Numbers:   001-03-ZEV, Former Biogen Idec: 106-I001
First Received:   September 13, 2005
Last Updated:   October 18, 2006
ClinicalTrials.gov Identifier:   NCT00168727
Health Authority:   United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Radioimmunotherapy  
Antigens, CD20  

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




Links to all studies - primarily for crawlers