Diffuse Large B-Cell Lymphoma Cancer Other and unspecified types of non-Hodgkin's lymphoma
Conditions
Interventions
Arm A: R-CHOP 21: eight cycles of CHOP and eight cycles of rituximab, every 21 days
Arm B: R-CHOP 14: six cycles of CHOP and eight cycles of rituximab, every 14 days
Please note that this trial has b
Sponsors
University College London (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years 2. Histologically proven Diffuse Large B Cell non-Hodgkin's Lymphoma (DLBCL) according to the current World Health Organisation (WHO) classification including all morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel 3. No previous chemotherapy, radiotherapy or other investigational drug for this indication 4. Bulky stage IA (defined as lymph node or lymph node mass greater than 10 cm in diameter), stage II, stage III and IV 5. WHO performance status zero to two 6. Adequate bone marrow function with platelets more than 100 x 10^9/l, neutrophils more than 1.5 x 10^9/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma 7. Serum creatinine less than 150mmol/l, serum bilirubin less than 35mmol/l and transaminases less than 2.5 upper limit of institutional normal range unless attributed to lymphoma 8. Normal MUltiple-Gated Acquisition (MUGA) scan or EchoCardioGram (ECG) without any areas of abnormal contractility. Patients must have an acceptable Left Ventricular Ejection Fraction (LVEF) = 50% (only applicable if aged over 70, known diabetic over 65, past history of cardiac disease or hypertension or abnormal resting ECG) 9. No concurrent uncontrolled medical condition 10. No active malignant disease other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last ten years 11. Life expectancy more than three months 12. Adequate contraceptive precautions for all patients of childbearing potential 13. Written, informed consent
Exclusion criteria
Exclusion criteria: 1. T-cell lymphoma or transformed follicular lymphoma 2. Previous history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed who have a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included 3. Past history of heart failure or uncontrolled angina pectoris 4. Central nervous system, meningeal involvement or cord compression by the lymphoma 5. Cardiac contra-indication to doxorubicin (abnormal contractility on echocardiography or nuclear medicine examination [MUGA]) 6. Neurological contra-indication to vincristine (e.g. pre-existing diabetic neuropathy) 7. Any other serious active disease 8. General status that does not allow the administration of eight courses of CHOP according to the investigator 9. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C 10. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Failure free survival 2. Toxicity 3. Complete response rates | — |
Countries
United Kingdom
Outcome results
None listed