Study title
Randomized Evaluation of Radotinib Versus Imatinib for Efficacy (RERISE China)
Scientific title
A Phase III, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Chinese Patients in Chronic Phase (RERISE China) (ClinicalTrials.gov no. NCT03722420)
Indication and most important inclusion criteria
This study includes male or female patients who:
- are at least 18 years old
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
- have been diagnosed with chronic myeloid leukemia (CML) in chronic phase (CP) within 6 months of enrolment
- have cytogenetically confirmed Philadelphia chromosome (Ph+) CML and typical BCR-ABL1 transcript such as b2a2 and b3a2
- have adequate organ function
Other criteria may apply.
Short description of intervention
This study will evaluate the efficacy of radotinib compared to imatinib 300 mg twice a day compared to imatinib 400 mg in patients with Ph+ CML in chronic phase.
Patients will be randomized to receive either radotinib 300 mg twice daily by mouth or imatinib 400 mg once a day by mouth. All patients will be treated and/or followed for 12 months (48 weeks) after randomization.
Type of study
First line trial
Current status
Recruiting
Study sponsor
Il-Yang Pharm. Co., Ltd.
Scientific lead / contact
Jeong Hye Kim, Il-Yang Pharm. Co., Ltd.
Bo Hwangbo, Il-Yang Pharm. Co., Ltd.
Principal investigator
Jiang Qian
Peking University People'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
China
Peking University People's Hospital
Beijing, 100044
Principal Investigator: Jiang Qian
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.
Randomization
In a clinical trial, patients are assigned by chance (often by a computer) to receive either one or the other treatment. This is to avoid bias in recruiting patients with specific characteristics into single arms of a trial.
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
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
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
ECOG
Eastern Cooperative Oncology Group Index to classify the quality of life of cancer patients on a scale ranging from 0 (fully active, able to carry on all predisease activities without restriction) to 5 (death).
Also often referred to as ECOG performance status.
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
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.
