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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00168727
First received: September 13, 2005
Last updated: October 18, 2006
Last verified: October 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin’s Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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

No publications provided

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

Keywords provided by Biogen Idec:
Radioimmunotherapy
Antigens, CD20

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013