Conditions: Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).

Detailed description:
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.

Arms:
arm 1: Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).

Interventions: intervention 1: Bexxar intervention 2: Acetaminophen intervention 3: Diphenhydramine intervention 4: Potassium Iodide (KI)
Intervention descriptions: intervention 1: 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:

* Platelet count of 150,000/mm³ = 75 cGy
* Platelet count ≥ 100,000/mm³ but \< 150,000/mm³ = 65 cGy intervention 2: As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain intervention 3: As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions intervention 4: Administered to prevent thyroid blockage 130 mg orally 3 times a day,

Protocol document: