Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
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|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.
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): NCT00490009
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Susan J Knox||Stanford University|