Phase II Study of Fractionated 90Y Ibritumomab tiuxetan (ZevalinTM) as initial therapy of Follicular Lymphoma - FIZZ Study

Phase 1

• Conditions: Follicular lymphoma LLT Follicle centre lymphoma, follicular grade I, II, III PT Follicle centre lymphoma, follicular grade I, II, III MedDRA Version 9

• Registration Number: EUCTR2006-000598-31-GB
• Lead Sponsor: Christie Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

•Patients must be aged 18 years or older.
•Patients must have a histologically confirmed CD20 +ve follicular lymphoma.
•Patients with at least one of the following symptoms requiring initiation of treatment: (as outlined by the modified BNLI/GELF criteria below)
Nodal mass > 5cm in its greater diameter
B symptoms
Elevated serum LDH or ?2-microglobulin
involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
symptomatic splenic enlargement
compressive syndrome
•Patients must have an ECOG performance status less than or equal to 2 (see Appendix 2) and an anticipated survival of at least 6 months.
•Patients must have an absolute granulocyte count of above 1,500/mm3, and a platelet count of above 100,000/mm3 post 4 weeks of unlabelled Rituximab.
•Patients must have adequate renal function (defined as serum creatinine <1.5 times upper limit of normal), hepatic function (defined as total bilirubin <1.5 times upper limit of normal), and hepatic transaminases (defined as AST <5 times upper limit of normal)

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

•Patients with a mean of >20% of the intratrabecular marrow space involved with lymphoma on bone marrow biopsy following induction Rituximab therapy.
•Patients with active obstructive hydronephrosis.
•Patients with initial disease bulk greater than 10cm.
•Patients with evidence of active infection requiring i.v. antibiotics at the time of study entry.
•Patients with advanced heart disease or other serious illness that would preclude evaluation.
•Patients with large pleural or peritoneal effusions.
•Patients with known HIV infection.
•Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 3 months following 90Y-ibritumomab tiuxetan antibody therapy.
•Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified