Trial evaluating the safety and efficacy of ponatinib induction followed by imatinib maintenance in adult patients with Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
- Conditions
- Patients with Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), all risk scores, =65 yearsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001789-41-FR
- Lead Sponsor
- Centre Léon Bérard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
I1. Male or female patients aged =18 and =65 years at time of inform consent signature
I2. Cytologically confirmed CML, Philadelphia chromosome positive with or without additional chromosomal abnormalities and/or BCR-ABL positive (Major BCR (M-BCR) transcript exclusively), i. e. Cryptic Philadelphia chromosome patients can be enrolled...
I3. No prior treatment for CML with any tyrosine kinase inhibitor (eg. imatinib, dasatinib, nilotinib or bosutinib), or busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; or any other investigational agent; with the exception of hydroxyurea and/or anagrelide which are the only authorized prior treatments
I4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2 (Appendix 1)
I5. Adequate organ functions as defined below according to lab tests performed within 7 days before Day 1...
I6. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before study drug start and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study treatments
I7. Fertile men must agree to use an effective method of contraception during the study and for up to 3 months after the last dose of study treatments
I8. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol
I9. Patients must be covered by a medical insurance
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
E1. Any form of prior auto- or allo-hemopoietic stem cell transplant
E2. Hypersensitivity to the active substance or to any of the excipients of ponatinib and imatinib (see respective IB/SmPC)
E3. Inability to take oral medication including malabsorption syndrome or other illness that could affect oral absorption of the study treatments (hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)
E4. Patients using, or requiring to use while on the study of any not permitted concomitant médications
E5. Patients with a malignancy other than CP-CML within 5 years prior to Day 1 with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated in situ carcinoma of the cervix, basal or squamous cell skin cancer, localised prostate cancer or ductal in situ carcinoma treated surgically with curative intent)
E.6 Patients with active B or C hepatitis infection
E.7 Patients with significant cardiovascular disease, such as New York Heart Association cardiac disease Class II or greater, myocardial infarction within 3 months prior to D1, unstable arrhythmias, unstable angina, peripheral arterial occlusive disease, brain stroke, heart stroke or evolutive ischemic cardiopathy, venous thromboembolism or pulmonary embolism; prolonged corrected QT interval (QTc) interval on baseline electrocardiogram (>450 msec on the Fridericia’s correction) despite correction of predisposants factors; long congenital QT syndrome
E.8 Any of the following medical conditions despite adequate therapeutic management :
?- Uncontrolled HTA despite adequate ongoing treatment
?- Diabetes with documented target organ damage
E9. Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method