A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03459534|
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia, Chronic Phase CML, Chronic Phase CML, Refractory CML - Philadelphia Chromosome||Drug: Radotinib HCl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||173 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||March 15, 2022|
|Estimated Study Completion Date :||April 1, 2023|
Experimental: Radotinib HCl
Enrolled subjects will continue to administer Radotinib 400mg twice daily (800mg/day) orally every 12 hours at regular dosing hours for 12 months.
Dose modification is allowed if the subject cannot comply with the protocol-defined dosing schedule due to hematologic or non-hematologic toxicities and toxicities resolve within 28 days (within 42 days for hematologic toxicities). For radotinib, maximum 2 dose reductions will be allowed by stage to 600mg and to 400mg.
Drug: Radotinib HCl
Other Name: SUPECT
- Major Cytogenetic Response (MCyR) [ Time Frame: at month 6 ]MCyR is defined as 0~35% CCyR+PCyR based on ≥20 metaphase myelocytes. Chromosome test results from <20 metaphase myelocytes will be excluded from the analysis.
- Cytogenetic Response (CCyR) [ Time Frame: at month 12/24, by month 24 ]CCyR is defined as complete loss of Ph chromosome based on ≥20 metaphase myelocytes. Chromosome test results from <20 metaphase myelocytes will be excluded from the analysis.
- Major molecular response [ Time Frame: at month 12/24, by month 24 ]MMR is defined as a ≥3-log reduction in BCR-ABL1 transcript level from the standardized reference or BCR-ABL1/ABL % of ≤0.1% according to the international reference when the level of BCR-ABL1 gene was measured by RQ-PCR, a standardized quantitative genetic method.
- Overall Survival(OS) [ Time Frame: by month 24 ]OS is defined as the duration from the first day of Radotinib administration to the day of death for certain causes.
- Progression Free Survival (PFS) [ Time Frame: by month 24 ]PFS is defined as the duration from the first day of Radotinib administration to the earliest day of disease progression or death for certain causes.
- BCR-ABL1 point mutation [ Time Frame: up to month 24 ]Incidence rate of BCR-ABL1 point mutations that are newly found during the course of radotinib treatment
- correlation between the concentration of radotinib in blood and the response (efficacy and safety) [ Time Frame: up to month 24 ]To measure the concentration of radotinib in blood
- Incidence of Radotinib-Adverse Events [ Time Frame: up to month 24 ]Toxicities will be evaluated in all subjects treated with radotinib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459534
|Contact: Hye Lin Parkfirstname.lastname@example.org|
|Contact: Na Yun Kimemail@example.com|
|Korea, Republic of|
|The Catholic University of Korea, Seoul ST. Mary's Hospital||Recruiting|
|Seoul, Korea, Republic of, 06591|
|Contact: Dong-Wook Kim, MD|
|Principal Investigator: Dong-Wook Kim|
|Ankara University Medical Faculty||Not yet recruiting|
|Contact: Muhit Ozcan, Prof.|
|Principal Investigator: Muhit Ozcan|
|Gazi University Medical Faculty||Not yet recruiting|
|Contact: Munci Yagci, Prof.|
|Principal Investigator: Munci Yagci|
|Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty||Not yet recruiting|
|Contact: Ahmet Eskazan, AProf|
|Principal Investigator: Ahmet Eskazan|
|Ege University Medical Faculty||Not yet recruiting|
|Contact: Guray Saydam, Prof.|
|Principal Investigator: Guray Saydam|
|Mersin University Medical Faculty||Active, not recruiting|
|Ondokuz Mayis Univ. Med. Fac.||Not yet recruiting|
|Contact: Mehmet Turgut, Dr.|
|Principal Investigator: Mehmet Turgut|
|CI Cherkasy Regional Oncological Dispensary of CRC||Not yet recruiting|
|Contact: Halyna Pylypenko|
|Principal Investigator: Halyna Pylypenko|
|CTPI Chernihiv Regional Oncological Dispensary||Not yet recruiting|
|Contact: Alla Nahorna|
|Principal Investigator: Alla Nahorna|
|CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC||Not yet recruiting|
|Contact: Anna Usenko|
|Principal Investigator: Anna Usenko|
|Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit||Not yet recruiting|
|Contact: Iryna Dyagil|
|Principal Investigator: Iryna Dyagil|
|SI Institute of Blood Pathology and Transfusion Medicine of AMSU||Not yet recruiting|
|Contact: Zvenyslava Maslyak|
|Principal Investigator: Zvenyslava Maslyak|
|Principal Investigator:||Dong Wook Kim||the Catholic University of Korea's St. Mary's Hospital|