A Phase IV single arm, multicenter, open-label study assessing deep molecular response in adult patients with newly diagnosed Philadelphia chromosome positive CML in chronic phase after two years of treatment with nilotinib 300mg BID
- Conditions
- The trial aims to evaluate the efficacy and quality of life of nilotinib 300mg BID in patients with chronic myleoid leukemia in chronic phase.MedDRA version: 20.0Level: LLTClassification code 10009700Term: CMLSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-000968-34-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
1. Male or female patients at least 18 years of age
2. ECOG 0, 1, or 2.
3. Patients within 6 months of diagnosis of CML in chronic phase with cytogenetic confirmation of Ph+ [t(9;22)
translocation]; if the bone marrow sample is taken within 12 weeks of the start of study treatment but before the
patient consents, the bone marrow should not be repeated after the patient formally consents to the study.
4. Documented chronic phase CML will meet all the criteria defined by:
1. < 15% blasts in peripheral blood and bone marrow,
2. < 30% blasts plus promyelocytes in peripheral blood and bone marrow,
3. < 20% basophils in the peripheral blood,
4. = 100 x 109/L (= 100,000/mm3) platelets,
5. No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
5. Patients must be previously untreated for CML with the exception of 6 months treatment with hydroxyurea and a
maximum of 6 weeks treatment with imatinib
6. Adequate end organ function as defined by:
• Total bilirubin < 1.5 x ULN (upper limit of normal) except know Mb. Gilbert
• AST (SGOT), ALT (SGPT) < 3 x ULN or = 5.0 x ULN if considered due to leukemia
• Creatinine < 1.5 x ULN
• Serum amylase and lipase = 1.5 x ULN
• Alkaline phosphatase = 2.5 x ULN unless considered tumor related.
7. Normal serum levels = LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin
or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication
8. Ability to provide written informed consent prior to any study related screening procedures being performed.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. Contraindication to excipients in study medication
2. Known impaired cardiac function, including any of the following:
•Congenital long QT syndrome or a known family history of long QT syndrome
•History of or presence of clinically significant ventricular or atrial tachyarrhythmias
•Clinically significant resting bradycardia (<50 beats per minute)
•QTcF >450 msec (using the QTcF formula). If QTcF > 450 msec and electrolytes are not within normal ranges,
electrolytes should be corrected and the patient re tested for the QTc
•History of clinically documented myocardial infarction within 12 months prior to study entry
•History of unstable angina during the last 12 months
•Other clinical significant heart disease (congestive heart failure)
3. History of acute (within 1 year of starting study medication) or chronic pancreatitis
4. Severe and/or uncontrolled concurrent medical conditions that in the opinion of the investigator could cause
unacceptable safety risks or compromise compliance with the protocol (e.g., acute artherothrombotic events (such as
ischemic heart disease, acute peripheral arterial occlusive disease, symptomatic carotid stenosis/cerebrovascular
accident), uncontrolled diabetes mellitus, active or uncontrolled infections, uncontrolled severe hypertension, and
uncontrolled severe dyslipidemia, acute or chronic liver or severe renal disease.
5. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
6. History of significant congenital or acquired bleeding disorder unrelated to cancer
7. Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers
(see http://medicine.iupui.edu/clinpharm/ddis/main-table/)
or medications that have the potential to prolong the QT interval
(see https://www.crediblemeds.org/pdftemp/pdf/CombinedList.pdf) which cannot be either discontinued or switched to
a different medication prior to starting study drug
8. Patients who have not recovered from prior surgery
9. Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior
to baseline and (d) female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post-
menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are
using highly effective methods of contraception during dosing and for 14 days after the final dose of nilotinib. Patients
using an oral hormonal contraception method should complete their monthly treatment course. Highly effective
contraception methods include:
•Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
•Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
•Male sterilization (at least 6 months prior to screening). For fe
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