Follicular lymphoma Cancer Follicular [nodular] non-Hodgkin's lymphoma
Conditions
Interventions
Control arm (R-CVP):
Rituximab 375 mg/m^2 intravenous (IV) day 1, cyclophosphamide 750 mg/m^2 IV day 1, vincristine 1.4 mg/m^2 IV day 1, prednisolone 40 mg/m^2 orally (PO) day 1 - 5, r
Sponsors
University of Liverpool (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed follicular lymphoma, grade 1, 2, and 3a with material available for central review 2. Ann Arbor stage II - IV, i.e. all patients except those with strictly localised disease for whom local radiotherapy would be appropriate. Lymph nodes should be considered pathologically enlarged if the long axis is more than 1.5 cm regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is more than 1.0 cm. 3. Aged 60 years or over (or less than 60 but more intensive chemotherapy considered inappropriate due to co-morbidity), either sex 4. At least one of the following British National Lymphoma Investigation (BNLI) criteria for initiation of treatment: 4.1. Rapid generalised disease progression in the preceding 3 months 4.2. Life threatening organ involvement 4.3. Renal of macroscopic liver infiltration 4.4. Bone lesions 4.5. Presence of systemic symptoms or pruritus 4.6. Haemoglobin less than 10 g/dL or whole blood cell count (WBC) less than 3.0 × 10^9/L or platelet count less than 100 × 10^9/L due to marrow involvement 5. Adequate haematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to registration: 5.1. Haemoglobin greater than or equal to 8.0 g/dL 5.2. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L 5.3. Platelet count greater than or equal to 100 x 10^9/L 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior anti-lymphoma treatment 2. Overt transformation to diffuse large B-cell lymphoma 3. World Health Organization (WHO) performance status 3 or 4 4. Creatinine clearance less than 30 ml/min 5. Serum bilirubin more than twice upper limit of normal (unless due to lymphoma) 6. Life expectancy less than 12 months 7. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Patients with any serological evidence of current or past exposure to HIV, hepatitis B or hepatitis C are excluded unless the serological findings are clearly due to vaccination. 8. Allergy to murine proteins 9. Grade 3b follicular lymphoma 10. Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis) 11. Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to less than 20 mg/day prednisolone 12. Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer 13. Major surgery (excluding lymph node biopsy) within 28 days prior to registration 14. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease) 15. Treatment within a clinical trial within 30 days prior to trial entry 16. Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent 17. Adult patient under tutelage (not competent to sign informed consent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression free survival (PFS): length of PFS defined as number of days between date of randomisation and the date of progression, date of death from any cause or the date last seen progression free (censor date) 2. Toxicity: grade 3 - 4 infection will be used as the toxicity end-point. Toxicity will be measured according to standard National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 following each cycle of treatment and at each subsequent follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rates (overall, complete and partial) following initial therapy - assessment made following initial therapy 2. Response rates following maintenance therapy - assessment made following maintenance therapy 3. Response duration - time to event outcome 4. Overall survival - time to event outcome 5. Time to treatment failure - time to event outcome 6. Time-to-next treatment - time to event outcome 7. Number of treatment cycles delivered - assessment made following second-line therapy 8. Cumulative dose of individual drugs administered - assessment made following initial therapy 9. Quality of life - EORTC QLQ C-30, EQ-5D and EQ-VAS questionnaires will be completed at various time points during the course of treatment and follow up 10. Cost effectiveness - will be assessed at various time points during the course of treatment and follow up 11. Response to second-line therapy - assessment made following second-line therapy | — |
Countries
United Kingdom
Outcome results
None listed