Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
07/08/2009
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 P Shepherd

ORCID ID

Contact details

Department of Haematology
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002869

Protocol/serial number

G8223452

Study information

Scientific title

Acronym

Study hypothesis

To determine whether there is any significant difference between the duration of chronic phase and overall survival in patients given low-dose alpha IFN, to study toxicity profiles in the two arms of the trial as assessed by WHO criteria and by percentage of patients requiring dose reduction or abandoning therapy because of side effects, to study haematologic and cytogenetic response at six monthly intervals on treatment with either low-dose or high-dose alpha IFN.

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

Intervention

High/low-dose Interferon (IFN).
Optional use of arm-C in addition to randomised IFN therapy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Overall survival
2. Frequency of haematologic and cytogenetic response
3. Duration of chronic phase and overall survival
4. Toxicity profiles
5. Side effects
6. Performance status
7. Quality of life

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1995

Overall trial end date

01/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed, previously untreated CML in chronic phase (therapeutic or back up leucapheresis does not preclude entry to the trial. Patients may be started on hydroxyurea for up to 4 weeks before randomisation)
2. The presence of the Ph chromosome or molecular evidence of Breakpoint Cluster Region (BCR)/Abelson (ABL) re-arrangement
3. World Health Organisation (WHO) performance status is 0./1, or 2 4. There is informed consent in accordance with MRC requirements and that of local ethics committees
5. Adequate hepatic and renal functions defined by bilirubin and creatinine levels below twice the upper limit. The possibility of allogeneic Bone Marrow Transplant (BMT) does not preclude entry to the trial

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Received previous treatment for CML
2. WHO performance status 3 or 4
3. Accelerated phase or established blast crisis; severe concurrent hepatic, renal or cardio-vascular problems or a history of severe depression in the past
4. Pregnancy

Recruitment start date

01/04/1995

Recruitment end date

01/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Haematology
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.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

2004 results on http://www.ncbi.nlm.nih.gov/pubmed/15010373

Publication citations

  1. Results

    Kluin-Nelemans HC, Buck G, le Cessie S, Richards S, Beverloo HB, Falkenburg JH, Littlewood T, Muus P, Bareford D, van der Lelie H, Green AR, Roozendaal KJ, Milne AE, Chapman CS, Shepherd P, , Randomized comparison of low-dose versus high-dose interferon-alfa in chronic myeloid leukemia: prospective collaboration of 3 joint trials by the MRC and HOVON groups., Blood, 2004, 103, 12, 4408-4415, doi: 10.1182/blood-2003-10-3605.

Additional files

Editorial Notes