A phase III multicentre randomised clinical trial comparing rituximab with CHOP given every 14 days and rituximab with CHOP given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell non-Hodgkin’s lymphoma - R-CHOP 14 vs. 21
- Conditions
- ewly diagnosed diffuse large B cell non-Hodgkin's lymphoma
- Registration Number
- EUCTR2004-002197-34-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1080
a) Age ? 18 years.
b) Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) according to the current World Health Organisation classification14 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.
c) Bulky stage IA (defined as lymph node or lymph node mass greater than 10cm in diameter), stage II, stage III and IV.
d) No previous chemotherapy, radiotherapy or other investigational drug for this indication.
e) Written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
a) T-cell lymphoma or transformed follicular lymphoma.
b) 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.
c) Any medical condition compromising ability to tolerate chemotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the improvement in overall survival of rituximab combined with CHOP given every 14 days (R-CHOP 14) in comparison to rituximab with CHOP given every 21 days (R-CHOP 21);Secondary Objective: To assess failure free survival, toxicity up to and including 30 days from date of last treatment and complete response rates;<br> Primary end point(s): Overall survival<br><br>
- Secondary Outcome Measures
Name Time Method