Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma

This study has been terminated.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00057343
First received: March 31, 2003
Last updated: September 8, 2006
Last verified: September 2006
  Purpose

The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Zevalin (ibritumomab tiuxetan)
Drug: Rituxan (rituximab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of the Zevalin Therapeutic Regimen Plus Rituxan Compared With Rituxan Alone in Patients With Relapsed or Refractory Follicular NHL

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Event-free survival

Secondary Outcome Measures:
  • overall response rate
  • complete response rate
  • unconfirmed complete response rate
  • partial response rate
  • duration of response
  • time to progression
  • time-to-next anticancer therapy
  • quality of life
  • overall survival
  • safety profile

Estimated Enrollment: 400
Study Start Date: March 2003
  Eligibility

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

Summary of major inclusion and exclusion criteria. Other Safety criteria will need to be met.

Inclusion Criteria:

  • Histologically confirmed, relapsed or refractory CD20+ follicular B-cell NHL within 12 months of Study Day 1 (without clinical evidence of transformation). NHL must require treatment as determined by an increase in overall tumor size. The presence of B symptoms, and/or the presence of masses which are causing ongoing clinical symptoms.
  • Bidimensionally measurable disease meeting the minimum requirement of at least 1 lesion >/= 2.0 cm in a single dimension.
  • No lymphoma therapy for 3 weeks prior to Study Day 1.
  • Patients must be recovered from all toxicities associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy.
  • Signed IRB-approved informed consent.
  • Greater than 18 years of age.
  • Expected survival >/= 3 months.
  • WHO performance status of </= 2.
  • Acceptable hematologic status, liver function, renal function, and pulmonary function.
  • Female patients who are not pregnant or lactating.
  • Men and women of reproductive potential who are following accepted birth control methods.

Exclusion Criteria:

  • Patients with impaired bone marrow reserve, which may be indicated by prior myeloablative therapy with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
  • Prior radioimmunotherapy, including the Zevalin regimen.
  • Prior immunotherapy, including Rituxan therapy within 6 months of Study Day 1.
  • Rituxan-refractory (no response to most recent Rituxan-containing regimen, or TTP was < 6 months).
  • Presence of CNS lymphoma.
  • Patients with chronic lymphocytic leukemia (CLL).
  • Known history of HIV or AIDS.
  • Serious nonmalignant disease or infection
  • Major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
  • Patients who received investigational product within 4 weeks of Study Day 1 or patients who may experience long-term toxicity from a previous investigational therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057343

  Show 67 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00057343     History of Changes
Other Study ID Numbers: 106-10
Study First Received: March 31, 2003
Last Updated: September 8, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014