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)

ISRCTN	ISRCTN65655917
DOI	https://doi.org/10.1186/ISRCTN65655917
Secondary identifying numbers	EORTC 20981

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 22/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr N/A N/A
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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)
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Lymphoma (non-Hodgkin's)
Intervention	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.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	11/11/1998
Completion date	11/11/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	465
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	11/11/1998
Date of final enrolment	11/11/2005

Locations

Countries of recruitment

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

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

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

83, Avenue E. Mounier
Bte 11
Brussels
B-1200
Belgium

Phone	+32 (0)2 774 16 41
Email	eortc@eortc.be
Website	http://www.eortc.be
"ROR"	https://ror.org/034wxcc35

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/05/2010		Yes	No

Editorial Notes

22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)