Short Chemo Radio Immunotherapy in Follicular Lymphoma Trial of Y-90 ibritumomab tiuxetan (Zevalin®) as therapy for first and second relapse in follicular lymphoma

Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 50 人开始时间: 2008年7月10日最近更新: 2022年8月15日

适应症

试验速览

•1. Both males and females. Patients must be aged 18 years or older
•2. Patients must have a histologically confirmed CD20 +ve follicular lymphoma
•3. Patients with at least one of the following symptoms requiring initiation of treatment (as outlined by the modified British National Lymphoma Investigation [BNLI]/Groupe d'Etude des Lymphomes Folliculaires [GELF] criteria):
•3.1. Nodal mass >5 cm in its greater diameter
•3.2. B symptoms
•3.3. Elevated serum lactate dehydrogenase (LDH) or beta-2-microglobulin
•3.4. Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
•3.5. Symptomatic splenic enlargement
•3.6. Compressive syndrome
•4. Patients must have an World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (ECOG-PS) less than or equal to 2 and an anticipated survival of at least 6 months
•5. First or second relapse after R-chemo (rituximab plus chemotherapy) 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
•6. 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 aspartate transaminase [AST] <5 times upper limit of normal)
•7. Patients must have given written informed consent prior to study entry

•1. Patients who have received investigational drugs <4 weeks prior to entry or who have not recovered from the toxic effects of such therapy
•2. Patients who have received previous radioimmunotherapy
•3. Patients with active obstructive hydronephrosis
•4. Patients with initial disease bulk greater than 10 cm
•5. Patients with central nervous system (CNS) disease
•6. Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry
•7. Patients with advanced heart disease or other serious illness that would preclude evaluation
•8. Patients with large pleural or peritoneal effusions
•9. Patients with known HIV infection
•10. Known hypersensitivity to murine antibodies or proteins
•11. Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 12 months following Y-90 ibritumomab tiuxetan (Zevalin®) antibody therapy
•12. 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 (UK)