Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Biological: 90-Y-ibritumomab tiuxetan; Biological: rituximab; Radiation: indium In 111 ibritumomab tiuxetan

• Registration Number: NCT00005592
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma.

OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8 immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2000-05-02
• Primary Completion: 2002-03
• Study First Submitted QC: 2003-12-15
• Study First Posted: 2003-12-16
• Study Completion: 2005-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8	90-Y-ibritumomab tiuxetan	For the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given. If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).
Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8	indium In 111 ibritumomab tiuxetan	For the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given. If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).
Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8	rituximab	For the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given. If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).

Primary Outcome Measures

Name	Time	Method
To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols.	up to 4.25 years

Secondary Outcome Measures

Name	Time	Method
To add to the overall efficacy and safety experience in this indication.	up to 4.25 years

Trial Locations

Locations (2)

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States