Phase II randomised study of fludarabine/cyclophosphamide combination with or without rituximab in patients with untreated mantle cell lymphoma
ISRCTN | ISRCTN81133184 |
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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
Scientific
Cancer Sciences Building, MP 824
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Phone | +44 (0)23 8079 6185 |
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Johnsonp@soton.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Study objectives | 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(s) | Ethics approval received from Multicentre Research Ethics Committee (ref: 02/6/31) |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/10/2002 |
Completion date | 22/02/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 151 |
Key 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 |
Key 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 |
Date of first enrolment | 01/10/2002 |
Date of final enrolment | 22/02/2005 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
Study participating centre
Cancer Sciences Building, MP 824
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
University College London (UK)
University/education
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/ |
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https://ror.org/02jx3x895 |
Funders
Funder type
Government
Southampton University Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/02/2016 | Yes | No |
Editorial Notes
30/11/2015: Publication reference added.