Actively Recruiting
A Phase 3 Study of Radotinib for Efficacy and Safety in Chronic Phase Ph+ Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy
Led by Il-Yang Pharm. Co., Ltd. · Updated on 2024-10-28
173
Participants Needed
18
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia who have not responded well or cannot tolerate previous tyrosine kinase inhibitor treatments, including Imatinib. This multinational Phase III study aims to assess the efficacy and safety of Radotinib in this specific patient group. A total of 173 participants are expected to enroll in this single-arm, open-label trial. Participants will receive Radotinib at a dose of 400 mg twice daily, taken orally every 12 hours, for 12 months. Dose adjustments may be made if participants experience certain blood-related or other toxicities, with up to two reductions allowed per stage to 600 mg and then 400 mg. The study monitors patients closely to manage any side effects and ensure compliance with the dosing schedule. Throughout the study, participants will undergo regular assessments, including cytogenetic and molecular response evaluations at 6, 12, and 24 months. Researchers will track major cytogenetic response at 6 months as the primary outcome, with additional measures of overall survival and progression-free survival by 24 months. Safety and tolerability will also be monitored, with follow-up lasting up to two years to evaluate long-term effects and disease progression.
CONDITIONS
Brief 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 or older
- Diagnosed with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia
- Failed or intolerant to previous tyrosine kinase inhibitor therapy including Imatinib
- ECOG performance status of 0, 1, or 2
- Chronic phase defined by blast and promyelocyte counts below specified thresholds, basophil count below 20%, and platelet count at least 50,000/mm3 (transient therapy-related thrombocytopenia allowed)
- No extramedullary leukemia involvement except liver and spleen enlargement
- Adequate organ function including specific limits for bilirubin, liver enzymes, creatinine, amylase, lipase, and alkaline phosphatase
- Negative pregnancy test within 14 days for women of childbearing potential
- Women of childbearing potential must use contraception during the study and for 1 month after last dose
You will not qualify if you...
- Previous diagnosis of accelerated phase or blast crisis CML
- Complete cytogenetic response at screening
- Impaired cardiac function including low ejection fraction, abnormal ECG findings, pacemaker, long QT syndrome, arrhythmias, or recent myocardial infarction
- Presence of T315I mutation
- Central nervous system leukemia involvement
- Severe or uncontrolled chronic diseases
- Significant bleeding disorders unrelated to leukemia
- Prior radiotherapy involving at least 25% of bone marrow
- Recent major surgery within 4 weeks before study drug administration
- Participation in other clinical studies or receiving other investigational products
- Inability to consent to the study
- Concurrent significant primary malignancies
- Current use of strong CYP3A4 inhibitors or inducers, therapeutic Cumarin derivatives, or drugs that prolong QT interval that cannot be discontinued
- Gastrointestinal disorders affecting drug absorption
- Recent history of pancreatitis
- Severe liver, pancreas, or kidney disease unrelated to leukemia
- HIV positive or active hepatitis B or C infection; stable treated hepatitis B or cured hepatitis C allowed
- Pregnancy or breastfeeding
- Unwillingness to use contraception during the study
- Hypersensitivity to Radotinib or its ingredients
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive Radotinib 400mg twice daily orally every 12 hours at regular dosing hours for 12 months. Dose modifications may be made if necessary due to toxicities.
Regular visits during the 12-month treatment period
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
K
Kang Hi An
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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