Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma Clinical Trial
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
| Verified date | September 2005 |
| Source | Biogen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Ottawa General Hospital | Ottawa | Ontario |
| Canada | Toronto-Sunnybrook Regional Cancer Center | Toronto | Ontario |
| United States | University of Maryland Cancer Center | Baltimore | Maryland |
| United States | Roswell Park Cancer Center | Buffalo | New York |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Robert H. Lurie Cancer Center, Northwestern University | Chicago | Illinois |
| United States | Texas Oncology, P.A. | Dallas | Texas |
| United States | Rocky Mountain Cancer Center | Denver | Colorado |
| United States | City of Hope Natioal Medical Center | Duarte | California |
| United States | Michigan State University | East Lansing | Michigan |
| United States | M.D. Anderson Cancer Center | Houston | Texas |
| United States | University of Iowa General Hospital | Iowa City | Iowa |
| United States | Scripps Memorial Hospital | La Jolla | California |
| United States | UCSD Stem Cell Laboratory | La Jolla | California |
| United States | University of Kentucky Medical Center | Lexington | Kentucky |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | The West Clinic, P.C. | Memphis | Tennessee |
| United States | Hoag Hospital | Newport Beach | California |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | University of Rochester Cancer Center | Rochester | New York |
| United States | Sutter Cancer Center | Sacramento | California |
| United States | University of Texas Health Sciences Center | San Antonio | Texas |
| United States | Sidney Kimmel Cancer Center | San Diego | California |
| United States | University of California, San Francisco | San Francisco | California |
| United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
| United States | Louisiana State University | Shreveport | Louisiana |
| United States | St. Louis University Medical Center | St. Louis | Missouri |
| United States | Stanford University Medical Center | Stanford | California |
| United States | Kaiser Permanente Medical Center | Vallejo | California |
| United States | Georgetown University Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Biogen |
United States, Canada,
McLaughlin P, Grillo-López 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 indol — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall response rate | |||
| Secondary | time to disease progression | |||
| Secondary | progressive disease-free interval |