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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 31, 2003
Last Updated Date	September 8, 2006
Start Date ^ICMJE	March 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2005)	Event-free survival
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00057343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non-Hodgkin's Lymphoma
Intervention ^ICMJE	Drug: Zevalin (ibritumomab tiuxetan) Drug: Rituxan (rituximab)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	400
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00057343
Other Study ID Numbers ^ICMJE	106-10
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	September 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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