SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03459534

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT03459534 Leukemia, Myeloid, Chronic Phase
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Radotinib HCl

Description: Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib) Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder Storage conditions: Store in an airtight light proof container at room temperature.

Type: Drug

Radotinib HCl


Primary Outcomes

Description: 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.

Measure: Major Cytogenetic Response (MCyR)

Time: at month 6

Secondary Outcomes

Description: 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.

Measure: Cytogenetic Response (CCyR)

Time: at month 12/24, by month 24

Description: 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.

Measure: Major molecular response

Time: at month 12/24, by month 24

Description: OS is defined as the duration from the first day of Radotinib administration to the day of death for certain causes.

Measure: Overall Survival(OS)

Time: by month 24

Description: 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.

Measure: Progression Free Survival (PFS)

Time: by month 24

Other Outcomes

Description: Incidence rate of BCR-ABL1 point mutations that are newly found during the course of radotinib treatment

Measure: BCR-ABL1 point mutation

Time: up to month 24

Description: To measure the concentration of radotinib in blood

Measure: correlation between the concentration of radotinib in blood and the response (efficacy and safety)

Time: up to month 24

Description: Toxicities will be evaluated in all subjects treated with radotinib.

Measure: Incidence of Radotinib-Adverse Events

Time: up to month 24

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T315I

- Medical history of clinically confirmed myocardial infarction - Medical history of unstable angina (within last 12 months) - Other clinically significant cardiac disease 4. Patients with T315I point mutations 5. Patients with central nervous system involvement as cytopathologically confirmed 6. Severe or uncontrolled chronic disease 7. Significant medical history of congenital or acquired bleeding disorders that are not related to leukemia 8. Patients who previously received radiotherapy to at least 25% of the bodies with high portion of bone marrow 9. Patients who received the major surgery within 4 weeks before the initiation of the IP administration or who failed to recover from the surgery that was performed before then. --- T315I ---



HPO Nodes


HPO:
Chronic myelogenous leukemia
Genes 5
MPL BCR JAK2 KIT THPO
Leukemia
Genes 125
MPL RNASEH2B KRAS NPM1 TET2 MYD88 TSR2 RPL26 RPL27 TREX1 EFL1 PIGL SCN11A FLT3 PMS2 RPL35A EVC2 ABL1 CEBPA RARA NRAS WAS WIPF1 ATRX SH2B3 PDGFRA RB1 RNASEH2A PDGFRB CALR ARHGAP26 SH3GL1 RPS7 RPS10 NUMA1 GATA1 GATA2 RPS15A APC NSD1 ETV6 TCIRG1 DNAJC21 EVC SRP54 RPS17 NBN RPS19 SAMHD1 MSH2 RPS24 NUP214 RPS26 RPS27 RPS28 RPS29 MLLT10 RUNX1 XRCC4 CBFB CBL BCR ADAR TRIP13 ADA2 NSUN2 CREBBP PICALM GFI1 F13A1 F13B FANCA FANCC BLM FANCD2 FANCE NUTM1 JAK2 IFIH1 TYROBP MSH6 FANCG LIG4 PTPN11 SAMD9L THPO NF1 STS PIGA BRCA2 DYNC2LI1 PIK3CA SBDS GLI1 PIK3R1 BRD4 SETBP1 RNASEH2C LPP BUB1 BUB1B SCN9A SCN10A TREM2 MLF1 MLH1 ELANE DKC1 ATM HAX1 RPL35 GNB1 BUB3 CEP57 TAL1 KIT TAL2 RPL5 EP300 TP53 RPL11 KIF11 RPL15 DNMT3A RPL18
Myeloid leukemia
Genes 12
GATA2 F13A1 CBL ARHGAP26 F13B KRAS PTPN11 SAMD9L KIT SETBP1 NF1 NRAS