A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
|ClinicalTrials.gov Identifier: NCT03459534|
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Chronic Phase||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, 2020|
|Estimated Study Completion Date :||April 1, 2022|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459534
|Contact: Hye Lin Parkemail@example.com|
|Contact: Jeong Hye Kimfirstname.lastname@example.org|
|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||the Catholic University of Korea's St. Mary's Hospital|