RT51KRI03 = Radotinib in Chronic Phase Chronic Myeloid Leukemia [Republic of Korea, Turkey, Ukraine]

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RT51KRI03 = Radotinib in Chronic Phase Chronic Myeloid Leukemia [Republic of Korea, Turkey, Ukraine]

Last Updated: Tuesday, 21 January 2020 08:40 | Print

Study title

Efficacy and Safety of Radotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase With Failure or Intolerance to Previous TKIs

Scientific title

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs (ClinicalTrials.gov no. NCT03459534)

Indication and most important inclusion criteria

Male or female patients 18 years or older with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Patients can be considered for inclusion in the study if they were previously treated with a tyrosine kinase inhibitor (TKI) including imatinib but did not respond to or tolerate treatment. Kidney and liver function must be adequate

Other criteria may apply.

Short description of intervention

This study is conducted to evaluate the efficacy and safety of radotinib 400 mg twice daily for 12 months in patients with Ph+ CML in chronic phase who did not respond or were intolerant to previous TKI therapy.

Type of study

Trial after therapy failure or intolerance

Current status

Recruiting

Study sponsor

Il-Yang Pharm. Co., Ltd.

Scientific lead / contact

Hye Lin Park, Il-Yang Pharm. Co., Ltd.
Jeong Hye Kim, Il-Yang Pharm. Co., Ltd.

Principal investigator

Dong-Wook Kim, MD
The Catholic University of Korea's St. Mary's Hospital

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Korea, Republic of

Seoul
The Catholic University of Korea, Seoul
St. Mary's Hospital
Principal Investigator: Dong-Wook Kim
Seoul, 0659

Turkey

Ankara
Ankara University Medical Faculty
Principal Investigator: Muhit Ozcan

Ankara
Gazi University Medical Faculty
Principal Investigator: Munci Yagci

Istanbul
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Principal Investigator: Ahmet Eskazan

Izmir
Ege University Medical Faculty
Principal Investigator: Guray Saydam

Mersin
Mersin University Medical Faculty

Samsun
Ondokuz Mayis Univ. Med. Fac.
Principal Investigator: Mehmet Turgut

Ukraine

Cherkassy
CI Cherkasy Regional Oncological Dispensary of CRC
Principal Investigator: Halyna Pylypenko

Chernihiv
CTPI Chernihiv Regional Oncological Dispensary
Principal Investigator: Alla Nahorna

Dnipro
CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC
Principal Investigator: Anna Usenko

Kyiv
Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit
Principal Investigator: Iryna Dyagil

Lviv
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Principal Investigator: Zvenyslava Maslyak

Chronic Myeloid Leukemia

also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.

Philadelphia chromosome

A certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene)

Inclusion criteria

Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.

Chronic phase

The earliest phase of CML development.

Chromosome

A chromosome is a structure of DNA that carries the genetic makeup in the nucleus of the cell. Chromosomes contain giant chain molecules of DNA, coiled and folded as aggregates with specific proteins. Chromosomes ensure that during cell division the hereditary information is evenly distributed to the daughter cells. Normal human body cells have 46 chromosomes. Cancer cells can have a different number and/or structure of chromosomes.

Indication

In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.

Imatinib

Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec

Chronic

Long-lasting, slowly developping

TKIs

Tyrosine Kinase Inhibitors, a class of drugs that block an enzyme involved in the mechanism of division of cells

CML

Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.

Ph+

Abbreviation for "Philadelphia-Chromosome-positive", meaning the presence of a certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene).

CHR

Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.

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