A phase III multicentre randomised clinical trial comparing rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 14 days and rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell non-Hodgkin's lymphoma
- Conditions
- CancerDiffuse Large B-Cell LymphomaOther and unspecified types of non-Hodgkin's lymphoma
- Registration Number
- ISRCTN16017947
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1080
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of this study is overall survival.
- Secondary Outcome Measures
Name Time Method The secondary endpoints are:<br>1. Failure free survival<br>2. Toxicity<br>3. Complete response rates