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Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma
This study has been terminated.
Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00057343
  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 III

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab Ibritumomab tiuxetan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Study placed in the following topic categories:
Lymphatic Diseases
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
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009