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

eukaemia Research Fund (UK)0 sites45 target enrollmentJuly 5, 2004

Overview

Registry

who.int

Start Date

July 5, 2004

End Date

October 10, 2006

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

eukaemia Research Fund (UK)

•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

•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