Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma
|ClinicalTrials.gov Identifier: NCT01389076|
Recruitment Status : Terminated (Bexxar isn't being produced by the manufacturer as of Feb. 2014)
First Posted : July 7, 2011
Results First Posted : July 12, 2016
Last Update Posted : January 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: Bexxar Drug: Low Dose Methotrexate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Low-Dose Methotrexate and Iodine I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||June 2016|
Experimental: Treatment arm
Low dose methotrexate and Bexxar
Iodine I 131 tositumomab (Bexxar) is a radioimmunotherapy (RIT) drug. RIT is a treatment strategy designed to target radiation specifically to cancer cells by attaching a radioactive atom to a monoclonal antibody, an immune system protein that binds to a particular protein. The Iodine I 131 tositumomab (Bexxar) therapeutic regimen is delivered in two sets of intravenous infusions given about 7 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body.
Other Name: Iodine I 131 tositumomabDrug: Low Dose Methotrexate
Methotrexate is an antifolate drug. It interferes with cells' ability to copy their DNA. This mainly affects cells that are dividing frequently, such as immune system cells and cancer cells. Methotrexate will be used in this study to try to prevent the occurrence of HAMA by limiting your body's ability to produce anti mouse antibodies.
- Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment [ Time Frame: 7 weeks ]The percentage of patients that experience early onset HAMA conversion following treatment. Early-onset HAMA is defined as antimouse antibody levels (in blood serum) of at least 5 times the level of detection, occurring at or prior to the 7th week of I-131 tositumomab therapy.
- Percentage of Participants That Respond to Treatment [ Time Frame: 2 years ]
The overall response rate (PR [partial response] + CR [complete response]) was determined.
Partial response is defined as the regression of measurable disease with no new sites of disease.
Complete response is defined as the disappearance of all evidence of disease.
- The Percentage of Participants Alive at 2 Years [ Time Frame: 2 years ]Overall survival was examined at 2 years
- Median Progression Free Survival (PFS) Time [ Time Frame: 2 Years ]The median time patients survived without progression.
- Number of Participants That Experienced SAEs During Treatment. [ Time Frame: Up to week 13 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389076
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mark Kaminski, M.D.||University of Michigan|