ISRCTN82286322
Completed
Phase 3
Randomised phase III study on the effect of early intensification of rituximab in combination with two-weekly cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy followed by rituximab maintenance in elderly patients (66 to 80 years) with diffuse large B-cell lymphoma
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre0 sites600 target enrollmentAugust 23, 2007
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32730183/ (added 07/10/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with a confirmed histological diagnosis of Diffuse Large B\-Cell Lymphoma (DLBCL) based upon a representative histology specimen according to the World Health Organisation (WHO) classification
- •2\. DLBCL must be CD20 positive
- •3\. Ann Arbor stages II \- IV
- •4\. Greater than or equal to 66 and less than or equal to 80 years
- •5\. Age WHO performance status 0 to 2
- •6\. Written informed consent
Exclusion Criteria
- •1\. Intolerance of exogenous protein administration
- •2\. Severe cardiac dysfunction (New York Heart Association \[NYHA] classification III \- IV or Left Ventricular Ejection Fraction \[LVEF] less than 45%). Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last six months
- •3\. Severe pulmonary dysfunction (vital capacity or diffusion capacity less than 50% of predicted value) unless clearly related to Non\-Hodgkin lymphoma (NHL) involvement
- •4\. Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
- •5\. Significant hepatic dysfunction (total bilirubin greater than or equal to 30mmol/l or transaminases greater than or equal to 2\.5 x upper normal limit), unless related to NHL
- •6\. Significant renal dysfunction (serum creatinine greater than or equal to 150 umol/l or clearance less than or equal to 60 ml/min), unless related to NHL
- •7\. Clinical signs of severe cerebral dysfunction
- •8\. Suspected or documented central nervous system involvement by NHL
- •9\. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •10\. Testicular DLBCL
Outcomes
Primary Outcomes
Not specified
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