Follicular lymphoma Cancer Follicular [nodular] non-Hodgkin's lymphoma
Conditions
Interventions
This is an open-label, single-arm, non-randomised controlled trial.
Weeks 0, 3 and 6: Three cycles of rituximab 375 mg/m^2 (intravenous [IV]) + chemotherapy (R-Chemo)
for Zevalin®: if platelet count >150 x 10^9L, Zevalin® at 14.8 MBq/kg, or if platelet count between >100 x 10^9L and <150 x 10^9L, dose adjusted Zevalin® at 11.1 MBq/kg)
Total duratio
Sponsors
Southampton University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR), including combined complete response (CR) and partial response (PR). Follow-up: Weekly until Week 22, then at various intervals up to 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to disease progression 2. Time to next treatment 3. Response duration for the responders 4. Safety of the regimen under investigation | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed