Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102) - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00168740

Purpose

Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.

Condition	Intervention	Phase
Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma	Drug: rituximab	Phase III

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pivotal Phase III Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times Four Dosing of IDEC-C2B8 (IDEC-102) in Patients With Relapsed Low-Grade or Follicular B-Cell Lymphoma

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

overall response rate

Secondary Outcome Measures:

time to disease progression
progressive disease-free interval

Estimated Enrollment:	150
Study Start Date:	April 1995

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
CD20-positive lymphoma
Progressive, measurable disease
Sign informed consent
3 weeks beyond standard therapy
Good performance status
Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

Chronic lymphocytic leukemia
Lesions greater than or equal to 10 cm in diameter
CNS lymphoma
AIDS-related lymphoma
Pleural effusions or ascites secondary to lymphoma
Active, opportunistic infection
Serious nonmalignant disease
Prior investigational therapies, including prior anti-CD20 therapy
Recent major surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168740

Show 31 Study Locations

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Antonio J. Grillo-Lopez, M.D.

Biogen Idec

More Information

Publications of Results:

McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33.

Study ID Numbers:	IDEC-102-05
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00168740
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

rituximab
Rituxan
B-cell lymphoma

low-grade
follicular
anti-CD20 monoclonal antibody

Study placed in the following topic categories:

Immunoproliferative Disorders
Rituximab
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell
Antibodies, Monoclonal
Lymphatic Diseases

Antibodies
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma
Immunoglobulins

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 13, 2009