Follicular lymphoma LLT Follicle centre lymphoma, follicular grade I, II, III PT Follicle centre lymphoma, follicular grade I, II, III MedDRA Version 9
Conditions
Interventions
Trade Name: Zevalin
Product Name: Zevalin
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: Ibritumumab tiuxetan
Sponsors
Christie Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this project is to test the safety and efficacy of two fractions of 90Y ibritumomab tiuxetan in patients with previously untreated follicular lymphoma in a Phase II study. ; Secondary Objective: The secondary objectives are to evaluate the progression-free-survival (PFS) and the overall survival time: • Progression-free-survival (PFS). PFS is defined as the difference between the date of randomization and the date on which the patients progresses or dies from any cause. • Overall survival time. This endpoint is defined as the time interval between the date of randomization and the date of death (from any cause) of the patient. ; Primary end point(s): The primary efficacy end point in this study will be to evaluate the rate of partial response (PR), complete response (CR) and overall response rate (ORR) according to tumor response criteria according to the “International workshop to standardize response criteria for Non-Hodgkin´s lymphomas”. CR/unconfirmed (CRu) will be categorized as CR. Secondary end points time to disease progression and response duration for the responders. | — |
Countries
United Kingdom
Outcome results
None listed