Chronic myeloid leukaemia (CML) Cancer Myeloid leukaemia
Conditions
Interventions
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.
Sponsors
Leukaemia Research Fund (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Scotland, United Kingdom
Outcome results
None listed