A randomised phase III study of chimeric anti-CD20 monoclonal antibody (rituximab) with two-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate or high-risk non-Hodgkin?s lymphoma

Phase 3

Completed

• Conditions: Cancer; Lymphoma; on Hodgkin's Lymphoma (NHL)

• Registration Number: ISRCTN84611849
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2006-10-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1. Patients with a confirmed histologic diagnosis of Non-Hodgkins Lymphoma (NHL) according to the World Health Organisation (WHO) classification:
a. Mantle Cell Lymphoma (MCL)
b. Follicular Lymphoma (grade III) (FL III)
c. Diffuse Large B-Cell Lymphoma (DLBCL)
2. Low-intermediate, high-intermediate or high risk NHL according to age-adjusted International Prognostic Index (IPI) score
3. NHL must be CD20 positive
4. Age 65 years or more
5. WHO performance status zero to two
6. Written informed consent

Exclusion Criteria

1. Intolerance of exogenous protein administration
2. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II to IV) or Left Ventricular Ejection Fraction (LVEF) less than 45%
3. Significant renal dysfunction (serum creatinine greater than or equal to 150 mmol/l), unless related to NHL
4. Significant hepatic dysfunction (total bilirubin greater than or equal to 30 mmol/l or transaminases greater than or equal to 25 times normal level), unless related to NHL
5. Suspected or documented Central Nervous System involvement by NHL
6. Patients known to be Human Immunodeficiency Virus (HIV)-positive
7. Patients with active, uncontrolled infections
8. Patients with uncontrolled asthma or allergy, requiring steroid treatment
or treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localised lymphoma mass or infiltration
9. Story of active cancer during the past five years, except basal carcinoma of the skin or stage zero cervical carcinoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Event-free survival (i.e. time from registration to induction failure (i.e. no Complete Response [CR] or Complete Response uncertain [CRu] on induction treatment), death or relapse whichever occurs first)<br> 2. The time to failure of patients with induction failure is set at one day<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Complete response<br> 2. Overall survival measured form the time of registration<br> 3. Disease-free interval (duration of the first CR) measured from the time of achievement of CR to day of relapse or death from any cause (whichever occurs first)<br> 4. Toxicity<br>