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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36210045
Enrollment
50
Registered
2013-04-10
Start date
2005-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell CD20+ indolent non-Hodgkin Lymphoma Cancer Non-Hodgkin lymphoma, unspecified

Interventions

A retrospective study based in a clinical protocol conducted by a multidisciplinary team comprising clinical hematologists, nuclear medicine physicians, radiopharmacists, and nurses at MSUH Therapy w

Sponsors

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

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026