Short CHemo RadioImmunotherapy in Follicular Trial of 90Y Ibritumomab tiuxetan (ZevalinTM) as therapy for first and second relapse in Follicular Lymphoma - SCHRIFT

Southampton University Hospitals NHS Trust0 个研究点目标入组 60 人开始时间: 2007年6月14日最近更新: 2015年8月4日

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•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 <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).
•Patients must have given written informed consent prior to study entry.
•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 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.

发起方

Southampton University Hospitals NHS Trust