The European CUP trial: a randomised trial in adults with poor risk relapsed follicular non-hodgkin's lymphoma

INTERVENTION: Following registration all patients receive three, 3 week, cycles of chemotherapy with cyclophosphamide, adriamycin, vincristine and prednisone (CHOP). Patients who achieve a complete or partial response are randomised to one of three treatment groups: 1. Group A: Chemotherapy, three further cycles of CHOP. 2. Group B High dose therapy with cyclophosphamide and total body irradiation, 8 Gy or 12 Gy midplane dose in a single fraction at a dose rate of 0.15‐0.3 Gy/min, followed by unpurged ABMT. 3. Group C: High dose therapy with cyclophosphamide and total body irradiation, 8 Gy or 12 Gy midplane dose in a single fraction at a dose rate of 0.15‐0.3 Gy/min, followed by purged ABMT. Randomisation to Group A is optional. Prior to randomisation clinicians must choose to randomise between all treatment or Group 2 and Group 3 only. CONDITION: Lymphoma (non‐Hodgkin's) ; Cancer ; Lymphoma (non‐Hodgkin's) PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Relapsed follicular non‐Hodgkin's lymphoma, after a first or subsequent remission, requiring therapy because of at least one of the following: 1.1. B symptoms 1.2. Rapidly progressive disease 1.3. Bone marrow failure 1.4. Life threatening organ failure 2. Aged 15 ‐ 65 years 3. No central nervous system (CNS) involvement 4. No previous radiotherapy greater than 2000 cGy to the mediastinum or abdomen, precluding total body irradiation 5. No previous myeloablative therapy 6. No prior malignancies, except non‐melanomatous skin cancer or cervical carcinoma stage I 7. Adequate cardiac, neurologic, liver and renal function 8. No evidence of histlogically proven transformation