Follicular Lymphoma First and second relapse of Follicular Lymphoma grade 1, 2, 3a.
Conditions
Interventions
Trade Name: Zevalin
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: 90-Y Ibritumomab tiuxetan
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: eq
Sponsors
Southampton University Hospitals 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 [54] below and in Appendix 1). ? 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 WHO/ECOG performance status (ECOG-PS) [55] less than or equal to 2 (see Appendix 2) and an anticipated survival of at least 6 months. • First or second relapse after R-Chemo-regimen or chemotherapy alone. Relapse must have occurred at least 6 months after an R-Chemo regimen but may have occurred less than 6 months after chemotherapy alone • 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 who have received investigational drugs <4 weeks prior to entry or who have not recovered from the toxic effects of such therapy • Patients who have received previous radioimmunotherapy • Patients with active obstructive hydronephrosis. • Patients with initial disease bulk greater than 10cm. • Patients with CNS disease. • 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. • Known hypersensitivity to murine antibodies or proteins. • Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 12 months following 90Y-ibritumomab tiuxetan (Zevalin) 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 current standard approach is to use 6-8 cycles of Rituximab plus Chemotherapy regimens given every 3 weeks for 6-8 months. Abbreviated treatment regimens that deliver equally high or superior response rates and durations to this protracted "standard" would therefore be an attractive alternative for patients in the future. Therefore the primary research objective of this phase II study is to evaluate the response rate of 3 cycles of Rituximab plus chemotherapy (R-chemo) followed by 90Y ibritumomab tiuxetan (ZevalinTM) in first and second relapse of patients with follicular lymphoma. ;Secondary Objective: 1.To evaluate response rates and relapse free survival data to allow future comparison in a proposed Phase III study 2. To evaluate the improvement in the quality of response after 90Y ibritumomab tiuxetan (ZevalinTM) compared with after 3 cycles of R-chemo. (to determine how many patients convert from partial to complete response after 90Y ibritumomab tiuxetan) 3.To evaluate the toxicity of 90Y ibritumomab tiuxetan (Zevalin) when administered following 3 cycles of R-Chemo.;Primary end point(s): The primary end point in this study will be to evalute the overall response rate (ORR), including combined complete response (CR) and partial response (PR). Secondary end points are: •Time to disease progression •Time to next treatment •Response duration for the responders •Safety of the regimen under investigation | — |
Countries
United Kingdom
Outcome results
None listed