Contact information
Type
Scientific
Primary contact
Prof Peter Johnson
ORCID ID
Contact details
Cancer Sciences Building
MP 824
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 6185
Johnsonp@soton.ac.uk
Additional identifiers
EudraCT number
2005-003178-71
ClinicalTrials.gov number
NCT00053092
Protocol/serial number
N0231120090
Study information
Scientific title
The addition of Rituximab to Fludarabine and Cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma
Acronym
Study hypothesis
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma.
This is a randomised phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.
Ethics approval
Ethics approval received from Multicentre Research Ethics Committee (ref: 02/6/31)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cancer: untreated mantle cell lymphoma
Intervention
1. Fludarabine intravenous (IV) and cyclophosphamide IV on days 1 - 3
2. Rituximab IV on day 1 and fludarabine IV and cyclophosphamide IV on days 2 - 4
Treatment repeats every 28 days for 2 - 8 courses in the absence of disease progression or unacceptable toxicity.
Intervention type
Drug
Phase
Phase II
Drug names
Fludarabine/cyclophosphamide, rituximab
Primary outcome measure
1. Response rate
2. Time to disease progression
3. Toxicity
4. Overall survival
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/10/2002
Overall trial end date
22/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 years or older
2. Proven mantle cell lymphoma
3. Previously untreated disease at any stage requiring therapy
4. No previous chemotherapy
5. Life expectancy of at least 3 months
6. Signed and dated informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
151
Participant exclusion criteria
1. Known serological positivity for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
2. Pregnant or breast feeding
3. Concomitant uncontrolled serious medical conditions
4. Severe renal or hepatic impairment not related to lymphoma
5. Known hypersensitivity to murine proteins
6. Previous malignancy in the last 5 years (except non-melanomatous skin tumours and carcinoma in situ of the cervix)
7. Psychological illness or condition that prevents adequate trial compliance
Recruitment start date
01/10/2002
Recruitment end date
22/02/2005
Locations
Countries of recruitment
Australia, United Kingdom
Trial participating centre
Cancer Sciences Building, MP 824
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Cancer Research UK & UCL Cancer Trials Centre (CTC)
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Southampton University Hospitals NHS Trust (UK)
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
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26611473