A pilot 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

ISRCTN	ISRCTN56578157
DOI	https://doi.org/10.1186/ISRCTN56578157
Clinical Trials Information System (CTIS)	2004-000179-33
Protocol serial number	LRF 03/101
Sponsor	Leukaemia Research Fund (UK)
Funder	Leukaemia Research Fund (UK)

Submission date: 05/07/2004
Registration date: 05/07/2004
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-different-ways-of-giving-glivec-to-people-with-cml

Contact information

Prof Tessa Holyoake
Scientific

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

Phone	+44 (0)141 301 7881
Email	tlh1g@clinmed.gla.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	GIMI
Study objectives	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(s)	Multicentre research ethics committee (MREC) Scotland approved on the 16th September 2004 (MREC ref: 04/MRE00/52)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	10/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	45
Total final enrolment	45
Key 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
Key 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
Date of first enrolment	10/10/2004
Date of final enrolment	10/10/2006

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Professor of Experimental Haematology

Glasgow
G12 0XB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.