Short CHemo RadioImmunotherapy in Follicular Trial of 90Y Ibritumomab tiuxetan (ZevalinTM) as therapy for first and second relapse in Follicular Lymphoma - SCHRIFT
- Conditions
- Follicular LymphomaFirst and second relapse of Follicular Lymphoma grade 1, 2, 3a.
- Registration Number
- EUCTR2007-000222-51-GB
- Lead Sponsor
- Southampton University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method