Third Medical Research Council Trial in Chronic Lymphomatic Leukaemia

ISRCTN ISRCTN23736115
DOI https://doi.org/10.1186/ISRCTN23736115
Secondary identifying numbers G8223452
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
24/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof D Catovsky
Scientific

Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

Phone +44 (0)20 7352 8171
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThird Medical Research Council Trial in Chronic Lymphomatic Leukaemia
Study acronymMRC CLL3
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLeukaemia (chronic)
InterventionFollowing 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)anthracyclines
Primary outcome measureDeath and death related to CLL, response to treatment, toxicity and compliance
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1990
Completion date01/04/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants350
Key inclusion criteria1. 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
Key exclusion criteriaPatients 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.
Date of first enrolment01/04/1990
Date of final enrolment01/04/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Marsden Hospital
London
SW3 6JJ
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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

Editorial Notes

24/10/2019: No publications found. All search options exhausted.