Accelerated phase Chronic Myeloid Leukaemia (CML).
Conditions
Sponsors
STRAGEN France
ChemGenex Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Male or female patients aged 18 to 80 years. b) Patients diagnosed with Ph chromosome-positive or BCR-ABL positive CML in the accelerated phase confirmed by a bone marrow aspirate and/or biopsy including cytogenetics and molecular analysis that must be completed within 28 days prior to initiation of HHT c) Patients who have failed to respond to, or have relapsed on imatinib d) Estimated life expectancy of at least 12 weeks. e) Adequate performance status as defined by a grading of 2 or better on the ECOG Performance Status Criteria f) Female patients of child-bearing potential willing to use adequate contraception (oral contraceptive pill, IUD, surgical sterilization, depot injection, contraceptive patches or barrier method in combination with a spermicide) for the duration of and at least one month after the last dose of investigational product. g) Male patients willing to use adequate contraception for the duration of and at least three months after the last dose of investigational product. h) Patients who have given written informed consent having read and understood the subject information sheet. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Patients planned for allogeneic transplantation before the end of induction period. b) Prior stem cell transplantation. c) Patients previously treated with combination chemotherapy or autografting for accelerated phase disease. d) Patients with previous blastic phase. e) Subjects previously treated with HHT. f) Female patients who are pregnant (confirmed by a serum pregnancy test) or lactating. g) For patients who have received another investigational anti-leukemic product, a wash-out period of 2 times half-life of the product must be observed before initiation of treatment with HHT (at least 48h of wash-out). In case of grade 3-4 hematological toxicity related to any other investigational anti-leukemic product, patients should not begin treatment with HHT until blood count recovery. h) Anti-leukemic agents, other than hydroxyurea (HU) or anagrelide, within seven days prior to the initiation of treatment with HHT. Imatinib have to be stopped at least 48 hours before starting therapy with HHT. In case of grade 3-4 hematological toxicity related to imatinib, patients should not begin treatment with HHT until blood counts recovery. i) NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure. j) Creatinine levels more than 3 x ULN (upper limit of normal range) at the laboratory where the analysis was performed. k) Total serum bilirubin more than 3 x ULN in subjects without clinically suspected leukemic involvement of the liver. l) AST (SGOT) or ALT (SGPT) more than 5 x ULN in subjects without clinically suspected leukemic involvement of the liver. m) Any other reason, which the Investigator feels, would preclude safe inclusion of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of subcutaneous HHT in the management of patients with accelerated phase Chronic Myeloid Leukaemia (CML) who are refractory to, or have relapsed on imatinib mesylate.;Secondary Objective: To evaluate the cytogenetic and molecular response to the IMP.;Primary end point(s): A. Haematological response rate to treatment at the end of the induction phase (including the rate of complete haematological response and the rate of return to chronic phase. B. Safety: rate and grade of non-haematological adverse events and rate and duration of grade 4 haematological toxicity (as defined by the CTC-NCI criteria). | — |
Countries
United Kingdom
Outcome results
None listed