Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
09/10/2012
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

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CML IIIB

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration.

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

Condition

Leukaemia (chronic)

Intervention

There are four treatment arms, clinicians may choose to randomise between only arms 1 and 2, 3 and 4, 2 and 4 or to randomise between all treatment arms.

1. Regimen A: Induction therapy with busulphan followed by maintenance therapy with busulphan plus alpha-interferon.
2. Regimen B: Induction therapy with busulphan followed by maintenance therapy with busulphan only.
3. Regimen C: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea plus alpha-interferon.
4. Regimen D: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea only.

Intervention type

Drug

Phase

Not Specified

Drug names

Alpha-Interferon , busulphan , hydroxyurea

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/08/2000

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 75 years with either Ph positive or Ph negative chronic myeloid leukaemia in chronic phase. Patients over 75 years or patients unwilling to accept alpha-interferon, may be randomised to busulphan or hydroxyurea, but not interferon or no interferon
2. Adequate renal function
3. No severe concurrent hepatic, renal, cardiovascular, organic brain disease or psychiatric illness
4. Patients with established blast cell crisis or extramedullary granulocytic sarcomas are to be excluded
5. Patients with accelerated phase or platelet count below that specified in the protocol are not eligible

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/08/2000

Recruitment end date

01/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
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

Government

Funder name

UK Medical Research Council

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

Publication citations

Additional files

Editorial Notes