follicular B cell NHL MedDRA version: 9.1 Level: LLT Classification code 10024914 Term: Low grade lymphoma MedDRA version: 9.1 Level: LLT Classification code 10003899 Term: B-cell lymphoma
Conditions
Interventions
Trade Name: Zevalin
Product Name: 90Y-ibritumomab tiuxetan
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Other descriptive name: ibritumomab tiuxetan
Trade Name: Mabthera
Product Name:
Sponsors
VUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed (according to WHO classification) CD 20 positive follicular lymphoma, grade 1, 2 or 3a, stage II, III or IV (with indication for treatment following local guidelines) of all FLIPI scores. • Age 18 years or older, for stem cell mobilisation analysis age 18-61 years • Having received 6-8 courses of 1st line R-CVP therapy • WHO performance status 0 to 2 • Life expectancy of at least 6 months • PET positive partial remission on PET-CT scan after 6-8 R-CVP • Absolute neutrofil count (ANC) 1.5 x 109/l or higher • Platelet count of 150 x 109/l or higher • Hb > 6 mmol/l, (transfusion is allowed to achieve this) • Less than 25% bone marrow involvement after 6-8 R-CVP, measured by bone marrow biopsy. • Written informed consent obtained according to local guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any other anticancer treatment for NHL except the first line R-CVP • Prolonged cytopenia during first line induction chemotherapy requiring more than 2 weeks delay due to insufficient bone marrow reserve. • Prior external beam radiotherapy to > 25% of active bone marrow. (involved field or regional) • Prior myeloablative therapy • Patients who have not recovered from the toxic effects of the first line chemotherapy • Presence of gastric, central nervous system or testicular localisation at first diagnosis • Any other malignancy or history of prior malignancy except non-melanoma skin cancer or stage 0 cervical carcinoma within the past 10 years • Patients with pleural effusion or ascites • Patients with abnormal liver function ( bili > 1.5 ULN or ALAT > 2.5 ULN) • Active uncontrolled infection • Known diagnosis of HIV infection • Patients with abnormal renal function: serum creatinine > 2.5 ULN • Known hypersensitivity to murine antibodies or proteins • G-CSF or GM-CSF therapy within 2 weeks (or 4 weeks if pegylated) prior to adminstration of 90Y-Ibritumomab tiuxetan • Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter • Concurrent severe and/or uncontrolled medical disease which could compromise study participation • Patients who received any investigational drugs or underwent surgery less than 4 weeks before entry in this study or who have as yet not recovered from the side-effects of such treatment. • Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of this study • Patients unwilling or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the conversion rate of PR to CR (i.e. PET negativity) after a single dose of 90Y-ibritumomab tiuxetan (a dose of 14.8 MBq/kg or 0.4 mCi/kg, max 1184 MBq or 32mCi) in patients with grade 1 to 3a (according to WHO lymphoma classification 2008), stage II, III or IV follicular lymphoma with PET-positive partial remission on PET-CT scan following first line R-CVP therapy. ;Secondary Objective: -to estimate progression free survival (PFS) -to estimate time to next treatment (TTNT) (treatment indications: bulky lymphadenopathy, cytopenia, or other inacceptable complaints caused by growth of the follicular lymphoma.) -to compare biological characteristics of bone marrow and stem cell harvest before and after a single dose of 90Y-ibritumomab tiuxetan ;Primary end point(s): • Conversion rate of PR to CR (i.e. PET negativity) after a single dose of 90Y-ibritumomab tiuxetan (a dose of 14.8 MBq/kg or 0.4 mCi/kg, max 1184 MBq or 32mCi) in patients with grade 1-3a, stage II, III or IV follicular lymphoma with PET-positive partial remission following first line R-CVP therapy | — |
Countries
Netherlands
Outcome results
None listed