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| A pilot study of continuous imatinib mesylate (IM) versus pulsed imatinib with or without Lenograstim (recombinant human granulocyte colony stimulating factor [rHu-GCSF]) in CML patients who have achieved a complete cytogenetic response |
| Source of record | Leukaemia Research Fund |
| ISRCTN | ISRCTN56578157 |
| Serial number at source | 56578157 |
| Other organisations' reference numbers | None |
| Title of trial/grant title | A pilot study of continuous imatinib mesylate (IM) versus pulsed imatinib with or without Lenograstim (recombinant human granulocyte colony stimulating factor [rHu-GCSF]) in CML patients who have achieved a complete cytogenetic response |
| Acronym | GIMI |
| Disease or condition | Chronic Myeloid Leukaemia (CML) |
| Current status of trial | Open |
| Patient information material | Patient information sheets can be obtained from: Ms Karen Stewart Research Nurse & Data Management University of Glasgow Glasgow G31 2ER Tel: +44 (0)141 211 5930 Email: Karen.stewart.wig@northglasgow.scot.nhs.uk |
| Topic/hypothesis/clinical objectives | Imatinib mesylate (IM, Glivec, STI 571) induces complete cytogenetic responses in the majority of chronic myeloid leukaemia (CML) patients in chronic phase (CP). However almost all of these individuals have detectable disease at the molecular level (using quantitative reverse transcription polymerase chain reaction [Q-RT-PCR] on peripheral blood), and are therefore unlikely to be cured. IM resistant quiescent stem cells, may contribute to this residual level of disease. An anti-proliferative effect of IM on this cell population has been noted and the hypothesis is therefore that reversal of the quiescent state will restore IM sensitivity. By inducing cell-cycle activation with recombinant human G-CSF (Lenograstim, rHu-G-CSF) and/or interuption of IM therapy it is hoped to reverse the quiescence and sensitise these cells to IM, thus eradicating the disease |
| Design/methodology | Randomised pilot phase III trial |
| Eligibility criteria - inclusion | 1. Age ≥18 years 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 <2% (within 4 weeks of study entry) 4. All chronic Phase patients, with criteria as follows: a. <10% blasts in peripheral blood (PB) or bone marrow (BM) b. <30% blasts plus promyelocytes in PB or BM c. <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 |
| Eligibility criteria - exclusion | 1. Patients with serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or creatinine concentration >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 amenorrheic 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 |
| Randomised 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 |
| Sources of funding | Leukaemia Research Fund |
| Contact name(s) | Dr Tessa Holyoake and Dr Mark Drummond |
| Contact details | Haemato-Oncology Section Division of Cancer Sciences and Molecular Pathology University of Glasgow 3rd Floor Queen Elizabeth Building 10 Alexandra Parade Glasgow G31 2ER UK Tel: +44 (0)141 211 4676/8779 Fax: +44 (0)141 211 0414 Email: tlh1g@clinmed.gla.ac.uk/mwd3z@clinmed.gla.ac.uk |
| Further information | This trial register was updated in October 2003. Further information can be obtained from the lead researcher named above, or from the National Cancer Research Network database. |
| Date live in mRCT | 03 August 2004 |
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