Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00005592|
Recruitment Status : Completed
First Posted : December 16, 2003
Last Update Posted : October 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: 90-Y-ibritumomab tiuxetan Biological: rituximab Radiation: indium In 111 ibritumomab tiuxetan||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||March 2002|
|Actual Study Completion Date :||November 2005|
Experimental: Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8
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).
Biological: 90-Y-ibritumomab tiuxetan
IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells. It is used to deliver radiation therapy to kill lymphoma cells. This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
Other Name: IDEC-Y2B8
Rituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
Radiation: indium In 111 ibritumomab tiuxetan
IDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine. It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion. The physician will then be able to see and evaluate the location and concentration of the antibody in the body.
Other Name: IDEC-In2B8
- 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. [ Time Frame: up to 4.25 years ]
- To add to the overall efficacy and safety experience in this indication. [ Time Frame: up to 4.25 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005592
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, District of Columbia|
|Lombardi Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Study Chair:||Mansoor N Saleh, MD||University of Alabama at Birmingham|