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Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma (NHL): a phase III randomised clinical trial (Intergroup Collaborative Study)

Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma (NHL): a phase III randomised clinical trial (Intergroup Collaborative Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65655917
Enrollment
465
Registered
2002-08-19
Start date
1998-11-11
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

Lymphoma (non-Hodgkin's) Cancer Lymphoma (non-Hodgkin's)

Interventions

Arm 1: CHOP will be given at 3-week intervals. After three cycles patients will be evaluated for response. Patients with stable or progressive disease will go off study. A total of six cycles will be

Sponsors

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with Ann Arbour stages III or IV follicular NHL (at initial diagnosis) who have relapsed after a minimum of two adequate non-anthracycline containing systemic chemotherapy regimens. Patients pre-treated with other chemotherapy regimens are not eligible for this trial. 2. Patients should have achieved remission on at least one of the prior regimens (i.e. either on the first or second regimen) 3. Remission duration upon one of the prior regimens should have been at least 3 months 4. Previous treatment should have been at least 4 month of single agent therapy (e.g. chlorambucil) and/or at least four consecutive cycles of polychemotherapy (e.g. CVP) or purine analogues. Patients treated with chemotherapy not fulfilling these criteria are not eligible. 5. Follicular NHL according to the Revised European/American Lymphoma (REAL) classification, i.e. follicle centre lymphoma, follicular (provisional cytological grades I [small cell], II [mixed small cell and large cell], III [large cell]) 6. Must be CD20 positive lymphoma 7. At least one mass should be present measurable by two perpendicular diameters by either physical or radiological examination 8. Aged 18 years or above 9. World Health Organization (WHO) performance status 0, 1 or 2 10. Patient information and written informed consent according to the rules of the respective country

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

Australia, Belgium, Canada, Denmark, Egypt, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Kingdom

Outcome results

None listed

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