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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168740

Enrollment

150

Registered

2005-09-15

Start date

1995-04-30

Completion date

Unknown

Last updated

2005-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma

Keywords

rituximab, Rituxan, B-cell lymphoma, low-grade, follicular, anti-CD20 monoclonal antibody

Brief summary

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.

Interventions

DRUGrituximab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
overall response rate	—

Secondary

Measure	Time frame
time to disease progression	—
progressive disease-free interval	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026