Actively Recruiting
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
Led by Il-Yang Pharm. Co., Ltd. · Updated on 2024-10-28
173
Participants Needed
18
Research Sites
496 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.
CONDITIONS
Official Title
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years old or older
- Diagnosed with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia
- Failed or intolerant to previous tyrosine kinase inhibitors therapy including Imatinib
- ECOG performance status of 0, 1, or 2
- Chronic phase defined by: blast cells less than 15% in blood and bone marrow; sum of blast and promyelocyte cells less than 30% in blood and bone marrow; basophil count less than 20% in blood; platelet count at least 50,000/mm3 (transient thrombocytopenia due to prior therapy is acceptable); no extramedullary leukemia except liver and spleen enlargement
- Adequate organ function including total bilirubin less than 1.5 times upper limit of normal, SGOT and SGPT less than 2.5 times upper limit of normal, creatinine less than 1.5 times upper limit of normal, serum amylase and lipase less than or equal to 1.5 times upper limit of normal, alkaline phosphatase less than or equal to 2.5 times upper limit of normal if unrelated to tumor
- Women of childbearing potential must have a negative pregnancy test within 14 days before enrollment
- Women of childbearing potential must use effective contraception during the study and for at least 1 month after the last dose
You will not qualify if you...
- History of accelerated phase or blast crisis CML
- Patients with complete cytogenetic response at screening
- Impaired cardiac function including left ventricular ejection fraction below 45% or below normal limit, inability to measure QT intervals, complete left bundle branch block, pacemakers, congenital or family history of long QT syndrome, symptomatic ventricular or atrial tachyarrhythmias, resting bradycardia below 50 bpm, mean QTcF over 450 msec in three ECG tests, history of myocardial infarction or unstable angina within last 12 months, or other significant cardiac disease
- Presence of T315I point mutations
- Central nervous system involvement confirmed by cytopathology
- Severe or uncontrolled chronic disease
- Significant bleeding disorders unrelated to leukemia
- Prior radiotherapy covering at least 25% of the body with high bone marrow exposure
- Major surgery within 4 weeks before starting study drug or not recovered from surgery
- Participation in another clinical study receiving investigational product
- Unable to give consent
- Concurrent clinically significant primary malignancy
- Current treatment with strong CYP3A4 inhibitors, inducers, or therapeutic coumarin derivatives that cannot be stopped or switched
- Current treatment with medications prolonging QT intervals that cannot be stopped or switched
- Gastrointestinal disorders affecting drug absorption
- History of acute or chronic pancreatitis within past year
- Severe liver, pancreas, or kidney disease not related to leukemia
- Known HIV positive, active hepatitis B or C, or cirrhosis (stable treated hepatitis B carriers or cured hepatitis C allowed)
- Women who are pregnant, breastfeeding, have positive pregnancy test, or unwilling to use contraception
- Men unwilling to use contraception
- Hypersensitivity to radotinib or excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Territorial State Budgetary Institution
Barnaul, Russia, 656024
Not Yet Recruiting
2
Federal State Budgetary Institution of Science
Kirov, Russia, 610027
Actively Recruiting
3
Federal State Budgetary Institution
Moscow, Russia, 125167
Not Yet Recruiting
4
Hematology Centre based on City Clin. Hosp. n.a. S.P. Botkin
Moscow, Russia, 300186883
Actively Recruiting
5
Federal State Budgetary Institution
Saint Petersburg, Russia, 191024
Actively Recruiting
6
Federal State Budgetary Institution
Saint Petersburg, Russia, 197341
Actively Recruiting
7
Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si, Gyeonggi-do, South Korea, 11749
Actively Recruiting
8
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Actively Recruiting
9
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
Actively Recruiting
10
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Actively Recruiting
11
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Actively Recruiting
12
Mersin University Medical Faculty
Mersin, Turkey (Türkiye)
Actively Recruiting
13
Ondokuz Mayis Univ. Med. Fac.
Samsun, Turkey (Türkiye)
Actively Recruiting
14
CI Cherkasy Regional Oncological Dispensary of CRC
Cherkassy, Ukraine
Actively Recruiting
15
CTPI Chernihiv Regional Oncological Dispensary
Chernihiv, Ukraine
Actively Recruiting
16
CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC
Dnipro, Ukraine
Actively Recruiting
17
Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit
Kyiv, Ukraine
Actively Recruiting
18
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Lviv, Ukraine
Actively Recruiting
Research Team
N
Na Yun Kim
CONTACT
K
Kang Hi An
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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