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)

• Register: ISRCTN
• Last refreshed on: 19 November 2018
• Main ID: ISRCTN65655917
• Date of registration: 19/08/2002
• Prospective Registration: No
• Primary sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 11/11/1998
• Target sample size: 465
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN65655917
• Study type: Interventional
• Study design: Randomised controlled trial (Not Specified)
• Phase: Not Specified

Countries of recruitment

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

Contacts

• Name: N/A N/A

Key inclusion & exclusion 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: Does not match inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 given.

Arm 2: CHOP plus Mabthera. Mabthera (iv) given on first day of each cycle of CHOP. Stable or progressive patients after three cycles will go off the study. A total of six cycles will be given.

Primary Outcome(s)

Not provided at time of registration

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

EORTC 20981

Source(s) of Monetary Support

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

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 11/11/2005