Phase II randomised study of fludarabine/cyclophosphamide combination with or without rituximab in patients with untreated mantle cell lymphoma

ISRCTN ISRCTN81133184
DOI https://doi.org/10.1186/ISRCTN81133184
EudraCT/CTIS number 2005-003178-71
ClinicalTrials.gov number NCT00053092
Secondary identifying numbers N0231120090
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
30/11/2015
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

Prof Peter Johnson
Scientific

Cancer Sciences Building, MP 824
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone +44 (0)23 8079 6185
Email Johnsonp@soton.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe addition of Rituximab to Fludarabine and Cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma
Study objectivesDrugs 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(s)Ethics approval received from Multicentre Research Ethics Committee (ref: 02/6/31)
Health condition(s) or problem(s) studiedCancer: untreated mantle cell lymphoma
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Fludarabine/cyclophosphamide, rituximab
Primary outcome measure1. Response rate
2. Time to disease progression
3. Toxicity
4. Overall survival
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/10/2002
Completion date22/02/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants151
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2002
Date of final enrolment22/02/2005

Locations

Countries of recruitment

  • Australia
  • England
  • United Kingdom

Study participating centre

Cancer Sciences Building, MP 824
Southampton
SO16 6YD
United Kingdom

Sponsor information

University College London (UK)
University/education

Cancer Research UK & UCL Cancer Trials Centre (CTC)
90 Tottenham Court Road
London
W1T 4TJ
England
United Kingdom

Website http://www.ucl.ac.uk/cancertrials/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

Southampton University Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2016 Yes No

Editorial Notes

30/11/2015: Publication reference added.