Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
|ClinicalTrials.gov Identifier: NCT00490009|
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : February 28, 2017
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Bexxar Drug: Acetaminophen Drug: Diphenhydramine Drug: Potassium Iodide (KI)||Phase 2|
There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.
This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||June 2013|
Experimental: Bexxar + Total Body Irradiation (TBI)
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells.
Bexxar will be administered to provide the following patient-specific radiotherapy:
Other Names:Drug: Acetaminophen
As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain
Other Name: TylenolDrug: Diphenhydramine
As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions
Other Name: BenadrylDrug: Potassium Iodide (KI)
Administered to prevent thyroid blockage 130 mg orally 3 times a day,
- Clinical Response Rate [ Time Frame: 6 years ]Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
- Time to Progression (TTP) [ Time Frame: 1.5 months; 3 months; 6 months; or Not Progressed ]Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.
- Overall Survival (OS) Rate [ Time Frame: 6 years ]Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490009
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Susan J Knox||Stanford University|