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

Christie Hospital NHS Trust0 个研究点目标入组 80 人开始时间: 2006年9月18日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•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
•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

•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.

发起方

Christie Hospital NHS Trust