For Healthcare Professionals

Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)


About the study

This is a Phase III, multi-center, open-label, parallel, 2-arm, randomized study to evaluate the efficacy and safety of radotinib 300 mg Bis In Die(BID) versus imatinib 400 mg Quaque Die(QD). This study will be conducted in Chinese patients with newly diagnosed Ph+ Chronic Myelogenous Leukemia(CML)-Chronic Phase(CP) who are previously untreated for Chronic Myelogenous Leukemia(CML).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. China who are 18 years of age or older.
  2. Eastern cooperative oncology group (ECOG) score 0, 1, or 2.
  3. Patients with confirmed diagnosis of CML-CP within last 6 months.
  4. Patients with cytogenetically confirmed Ph+ CML in chronic phase
  5. Patients with typical BCR-ABL1 transcript type such as b2a2 and b3a2.
  6. Patients with adequate organ function.
  7. Women of childbearing potential should have negative serum or urine pregnancy test within 14 days before study entry.
  8. Patients providing written informed consent before initiation of any study-related activities.


Exclusion Criteria:

  1. Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML.
  2. Patients who had been treated with interferon or other targeted anti-cancer therapy which inhibits the growth of leukemic cells
  3. Concurrently clinically significant primary malignancy
  4. Patients who previously received radiotherapy
  5. Patients with impaired cardiac function.
  6. uncontrolled chronic medical condition

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Chronic Myeloid Leukemia, Chronic Phase

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Dec 31, 2023

Treatment type



Il-Yang Pharm. Co., Ltd. identifier


Study number


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