Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EORTC 20981
Study information
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)
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/11/1998
Overall trial end date
11/11/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
465
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
11/11/1998
Recruitment end date
11/11/2005
Locations
Countries of recruitment
Australia, Belgium, Canada, Denmark, Egypt, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Sponsor details
83
Avenue E. Mounier
Bte 11
Brussels
B-1200
Belgium
+32 (0)2 774 16 41
eortc@eortc.be
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20368567
Publication citations
-
Results
van Oers MH, Tönnissen E, Van Glabbeke M, Giurgea L, Jansen JH, Klasa R, Marcus RE, Wolf M, Kimby E, Vranovsky A, Holte H, Hagenbeek A, van der Reijden BA, BCL-2/IgH polymerase chain reaction status at the end of induction treatment is not predictive for progression-free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized EORTC 20981 phase III intergroup study., J. Clin. Oncol., 2010, 28, 13, 2246-2252, doi: 10.1200/JCO.2009.25.0852.