A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Resistance/Intolerance to Previous TKIs
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|ClinicalTrials.gov Identifier: NCT03459534|
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Chronic Phase||Drug: Radotinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||195 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Chronic Phase Chronic Myeloid Leukemia Patients With Resistance 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|
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.
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 Parkemail@example.com|
|Contact: Da Won Parkfirstname.lastname@example.org|
|Korea, Republic of|
|The catholic university of Korea, Seoul ST. Marry'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|