Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ucl.ac.uk/cancertrials/

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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26611473

Publication citations

Additional files

Editorial Notes

30/11/2015: Publication reference added.