Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
27/11/2012
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 D Catovsky

ORCID ID

Contact details

Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
+44 (0)20 7352 8171

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G8223452

Study information

Scientific title

Acronym

MRC CLL3

Study hypothesis

To establish whether the addition of epirubicin to standard chlorambucil therapy prolongs the duration of remission and survival, to evaluate the therapeutic benefit of anthracyclines in CLL by comparing the objective response rate to chlorambucil alone with that to chlorambucil + epirubicin, to assess the relative toxicities of two regimens.

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Leukaemia (chronic)

Intervention

Following randomisation stage C patients only receive pre-treatment with prednisolone. Patients are then treated on one of two treatment regimens depending upon the initial randomisation:
1. Regimen A: Chlorambucil orally daily for 6 days. Cycle repeated every 28 days.
2. Regimen B: Epirubicin on day 1 followed by chlorambucil orally for 6 days. Cycle to be repeated every 28 days.

Intervention type

Drug

Phase

Not Specified

Drug names

anthracyclines

Primary outcome measures

Death and death related to CLL, response to treatment, toxicity and compliance

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1990

Overall trial end date

01/04/1995

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients with B-cell chronic lymphoblastic leukaemia diagnosed by a persistent blood lymphocytosis (greater than 10 x 10^9/l) and bone marrow infiltration of at least 40% who require treatment
2. Previously untreated stage B and C disease
3. Stage A patients showing evidence of disease progression
4. Previously treated patients who:
4.1 Have not received an anthracycline or anthracenedione
4.2 Are not considered to be resistant to chlorambucil
4.3 Have relapsed off therapy and need further treatment because of disease progression
5. No concomitant treatment with any other cytotoxic or immunomodulatory therapy
6. No other life threatening disease
7. No medical contraindications to treatment protocols

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

350

Participant exclusion criteria

Patients who have another life threatening disease; they are not expected to complete the study treatment for other reasons; they are having concomitant treatment with any cytotoxic or immunomodulatory therapy; there is evidence of heart disease which would preclude treatment with anthracycline or they have not given informed consent.

Recruitment start date

01/04/1990

Recruitment end date

01/04/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Marsden Hospital
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes