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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002197-34-GB
Enrollment
1080
Registered
2005-02-17
Start date
2004-12-14
Completion date
Unknown
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed diffuse large B cell non-Hodgkin's lymphoma

Interventions

Product Name: Mabthera Pharmaceutical Form: Solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg/ml milligram(s)/millilitre

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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; Primary end point(s): Overall survival—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026