Radioimmunotherapy with 90Y Ibritumumab Tiuxetan in B-cell CD20+ indolent non-Hodgkin Lymphoma

Completed

• Conditions: B-cell CD20+ indolent non-Hodgkin Lymphoma; Cancer; Non-Hodgkin lymphoma, unspecified

• Registration Number: ISRCTN36210045
• Lead Sponsor: Foundation for the Study of hematology in Aragon [Fundación para el Estudio de la Hematologia y Hemoterapia en Aragón](FEHHA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified