Condition category
Cancer
Date applied
05/07/2004
Date assigned
05/07/2004
Last edited
17/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Tessa Holyoake

ORCID ID

Contact details

Professor of Experimental Haematology
Director of the Paul O'Gorman Leukaemia Research Centre
Faculty of Medicine
University of Glasgow
21 Shelley Road
Gartnavel General Hospital
Glasgow
G12 0XB
United Kingdom
+44 (0)141 301 7881
tlh1g@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

2004-000179-33

ClinicalTrials.gov number

Protocol/serial number

LRF 03/101

Study information

Scientific title

A pilot randomised controlled study of continuous imatinib mesylate (IM) versus pulsed imatinib with or without lenograstim (recombinant human granulocyte colony stimulating factor [rHu-GCSF]) in chronic myeloid leukaemia (CML) patients who have achieved a complete cytogenetic response

Acronym

GIMI

Study hypothesis

Continuous imatinib mesylate (IM) versus pulsed imatinib with or without lenograstim (recombinant human granulocyte colony stimulating factor [rHu-GCSF]) in chronic myeloid leukaemia (CML) patients who have achieved a complete cytogenetic response.

This trial is also listed in the the UK Clinical Research Network Study Portfolio: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=1451

Ethics approval

Multicentre research ethics committee (MREC) Scotland approved on the 16th September 2004 (MREC ref: 04/MRE00/52)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Chronic myeloid leukaemia (CML)

Intervention

Patients who are in complete cytogenetic remission for at least 6 months subsequent to IM therapy will be randomised to receive either pulsed IM, pulsed IM with G-CSF, or continuous IM.

Total duration of treatment: 12 months
Total duration of follow-up: 4 years

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Added 06/01/2010:
1. Safety of combination GCSF and imatinib
2. Safety of pulsed imatinib arms

Endpoints measured at end of last recruited patient 12 month treatment (September 2007) and then 4 years after this timepoint (September 2011).

Secondary outcome measures

Added 06/01/2010:
1. Molecular response to imatinib interruption
2. Proportion of patients progressing

Endpoints measured at end of last recruited patient 12 month treatment (September 2007) and then 4 years after this timepoint (September 2011).

Overall trial start date

10/10/2004

Overall trial end date

10/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than or equal to 18 years, either sex
2. Patients, who having been established on IM therapy at the appropriate licensed dose, have maintained a complete cytogenetic response for at least 6 months (confirmed on bone marrow [BM] performed within 3 months of study entry)
3. Patients who remain quantitative reverse transcription polymerase chain reaction (Q-RT-PCR) positive and have a peripheral blood (PB) Q-RT-PCR breakpoint cluster region-Abelson (BCR-ABL)/ABL ratio of less than 2% (within 4 weeks of study entry)
4. All chronic Phase patients, with criteria as follows:
4.1. Less than 10% blasts in peripheral blood (PB) or bone marrow (BM)
4.2. Less than 30% blasts plus promyelocytes in PB or BM
4.3. Less than 20% blasts in PB
5. Acute phase (AP) patients only if their definition of AP was based on karyotypic evolution on BM cytogenetics as an isolated feature of progression
6. Written voluntary informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. Patients with serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or creatinine concentration greater than 2 times the institutional upper limit of the normal range
2. Patients who have evidence of extramedullary disease
3. Treatment with investigational drugs within 28 days of study entry
4. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina or Grade 3 - 4 cardiac problems as defined by the New York Heart Association Criteria
5. Patients who have undergone major surgery within 4 weeks of study day 1, or who have not recovered from prior major surgery
6. Patients who are: pregnant, breast feeding, of childbearing potential without a negative pregnancy test prior to study entry or who are unwilling to use barrier contraception throughout the trial and for 3 months after cessation of therapy (postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
7. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable

Recruitment start date

10/10/2004

Recruitment end date

10/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Experimental Haematology
Glasgow
G12 0XB
United Kingdom

Sponsor information

Organisation

Leukaemia Research Fund (UK)

Sponsor details

43 Great Ormond Street
London
WC1N 3JJ
United Kingdom
sgerscher@lrf.org.uk

Sponsor type

Charity

Website

http://www.lrf.org.uk/

Funders

Funder type

Charity

Funder name

Leukaemia Research Fund (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19262595

Publication citations

  1. Results

    Drummond MW, Heaney N, Kaeda J, Nicolini FE, Clark RE, Wilson G, Shepherd P, Tighe J, McLintock L, Hughes T, Holyoake TL, A pilot study of continuous imatinib vs pulsed imatinib with or without G-CSF in CML patients who have achieved a complete cytogenetic response., Leukemia, 2009, 23, 6, 1199-1201, doi: 10.1038/leu.2009.43.

Additional files

Editorial Notes