Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
15/08/2012
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 I Franklin

ORCID ID

Contact details

Academic Transfusion Medicine Unit
Cancer Division
Section of Experimental Haematology
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G8223452

Study information

Scientific title

Acronym

CML 2000

Study hypothesis

To improve on the best current therapy in chronic phase CML for patients who do not undergo allogeneic BMT with respect to prolonging survival. The trial will compare the combination of a cycle of chemotherapy and an autograft with subsequent alpha IFN with alpha IFN therapy alone. Also, to compare whether low dose alpha IFN therapy is as effective as high dose alpha IFN therapy.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Leukaemia

Intervention

Cycle of chemotherapy and an autograft with subsequent IFN/IFN therapy alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Length of survival, quality of life, cytogenetic response

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

31/10/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. The interval from diagnosis to registration does not exceed 3 months (if received only hydroxyurea in these 3 months proceed to register, if alpha Interferon (IFN) has been given contact co-ordinators)
2. They are aged 18-60; they have newly diagnosed CML
3. They have acceptable criteria for chronic phase
4. They have given informed consent and are willing to be randomised, there is no contraindication to collection of blood or marrow progenitor cells before treatment is commenced
5. They are not pregnant

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

800

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1996

Recruitment end date

31/10/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Transfusion Medicine Unit, Cancer Division
Glasgow
G31 2ER
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