Acute Myeloid Leukaemia MedDRA version: 16.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Ponatinib
Product Code: AP24534
Pharmaceutical Form: Tablet
Sponsors
Cardiff Univeristy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •They have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia or CML in blast crisis as defined by the WHO Classification (Appendix A) — this can be any type of de novo or secondary AML •They have received a first induction chemotherapy course (Daunorubicin 3+10) •Have a FLT3 mutation •Serum Creatinine = 1.5 × ULN (upper limit of normal) •Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =2.5 × ULN •Serum lipase or amylase =1.5 × ULN •Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits, and every effort should be made to keep potassium at institutional normal limits, and every effort should be made to keep magnesium concentrations above 4.0 mEq/dL, and serum calcium at normal concentration •Female and Male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners while on study drug. •Age 18 to 60 years •Provided written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 153 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: •They have previously received cytotoxic chemotherapy other than the combination of Daunorubicin/ Ara-C as the first induction treatment. •They do not have documented a FLT3 mutation. •They are in blast transformation of chronic myeloid leukaemia (CML) •They have a concurrent active malignancy or a malignancy under treatment excluding basal cell carcinoma •They are pregnant or lactating •They have Acute Promyelocytic Leukaemia •Leukaemia involving the central nervous system. •Known infection with human immunodeficiency virus (HIV) •History of acute pancreatitis within 1 year of study or history of chronic pancreatitis •History of alcohol abuse •Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL) •Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to: a. Myocardial infarction, unstable angina and/or congestive heart failure within 3 months prior to randomization b. History of clinically significant (as determined by the treating physician) atrial arrhythmia; or any ventricular arrhythmia •Uncontrolled hypertension (diastolic blood pressure >100 mm Hg; systolic >150 mm Hg) •Taking medications that are known to be associated with Torsades de Pointes (Appendix C) • Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial is designed to identify whether the addition of these new agents will improve the efficacy of the current standard treatment, without excessive toxicity. ;Secondary Objective: During the trial we will also capture data about response to treatment, early (30-day and 8-week) mortality and any additional information relating to one of the drugs in particular (for instance, cardiac assessments). Supportive care requirements will also be noted, to inform the health economics aspect of treatment.;Primary end point(s): • Relapse Free Survival at 12 months • Response (CR, CRi, PR) achievement, and reasons for failure • 30 day and 8 week mortality • Toxicity, both haematological and non-haematological • Supportive care requirements | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
United Kingdom
Contacts
Public ContactMrs Angela M Grech
Cardiff University
Outcome results
None listed