B-cell CD20+ indolent non-Hodgkin Lymphoma Cancer Non-Hodgkin lymphoma, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults patients with an excisional biopsy-confirmed diagnosis of CD20+ F-NHL grade 1, 2, or 3a according to the revised WHO classification system 2. ECOG performance status = 2 3. Absolute neutrophil count (ANC) = 1,500/µL 4. Absolute platelet count (APC) = 100,000/µL 5. Bone marrow total lymphocytes = 25% by morphological counting 6. Serum bilirubin = 2.0mg/dL and serum creatinine = 2.0mg/dL 7. All patients were requested to sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. This does not apply to-non melanoma skin tumors and in situ cervical cancer. 2. Prior radioimmunotherapy 3. Presence of primary central nervous system (CNS) lymphoma at first diagnosis 4. Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg). 5. Known history of HIV infection 6. Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease. 7. Abnormal renal function: serum creatinine > 2.0 × ULN 8. Ongoing toxic effects of chemotherapy > grade 2 and expected to interfere with Zevalin® treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response assessment was made 12 weeks after treatment PET/CT scan was performed in all cases and response criteria used were the same as the International Working Group (IWG). and classified as Complete Response (CR), Partial Response (PR) and no response (NR). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to Progression (TTP) 2. Overall Response (OR) and OS in all patients. 3. We also registered side effects, with special emphasis in myelotoxicity and emerging second neoplasms. TTP and OS were calculated from the date of 90Y-IT therapy until disease progression or death. All eligible patients were accepted by the clinical committee and included into the analysis. | — |
Countries
Spain