Non Hodgkin's lymphoma (NHL) Cancer Lymphoma
Conditions
Interventions
Patients will be randomised between:
Arm A: Three courses of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every three weeks.
Arm B: Three
Sponsors
Daniel den Hoed Kliniek (Erasmus Medical Centre) (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients with a primary Non Hodgkin?s Lymphoma (NHL) of intermediate or high grade malignancy according to the Working Formulation (group D, E, F, G, H) 2. Belonging to the intermediate risk group: a. stage II, Lactate Dehydrogenase (LDH) greater than or equal to 1.5 x normal b. stage III, LDH greater than 1.5 x normal c. stage IV, LDH less than 1.5 x normal 3. Age greater than or equal to 15, or less than or equal to 65 years
Exclusion criteria
Exclusion criteria: 1. Patients with prior malignancies, except stage one cervix carcinoma and basocellular carcinoma 2. Patients with severe cardiac (means severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%) pulmonary, neurologic or metabolic disease. 3. Inadequate liver or renal function i.e. serum creatinine or bilirubin greater than 25 x the upper normal value, except when related to the lymphoma 4. Human Immunodeficiency Virus (HIV) positivity 5. Inability to give informed consent 6. Involvement of the central nervous system by the NHL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate and overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-free survival 2. Relapse rate 3. Assessment of value of risk factors at diagnosis in relation to dose intensity of the treatment 4. Morbidity, number of days in hospital, treatment-related mortality, duration of leucopenia and other aspects in relation to dose intensity | — |
Countries
Netherlands
Outcome results
None listed