Clinical Trials /

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

NCT03722420

Description:

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).

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: RT51CN03
  • NCT ID: NCT03722420

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase

Interventions

DrugSynonymsArms
RadotinibRadotinib 300mg
ImatinibImatinib 400mg

Purpose

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).

Detailed Description

      Patients randomized to the radotinib arms will receive 300 mg of radotinib BID at
      approximately 12-hour intervals. Patients randomized to the imatinib 400 mg arm will receive
      imatinib once a day throughout the study.

      The primary efficacy endpoint is the rate of Major Molecular Response(MMR) at 12 months (1
      month = 4 weeks = 28 days), defined as BCR ABL1/ABL% ≤ 0.1% by international scale. The
      Molecular Response(MR) rate will be measured every 3 months by Real-time
      Quantitative(RQ)-Polymerase Chain Reaction(PCR) in a central laboratory. All patients will be
      treated and/or followed for 12 months (48 weeks) after randomization.
    

Trial Arms

NameTypeDescriptionInterventions
Radotinib 300mgExperimentalOral adminstration of Radotinib 300mg BID (600mg/day) for 12months
  • Radotinib
Imatinib 400mgActive ComparatorOral administration of Imatinib 400mg QD (400mg/day) for 12months
  • Imatinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The MMR rate
Time Frame:at 12 months after radotinib or imatinib treatment
Safety Issue:
Description:The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.

Secondary Outcome Measures

Measure:MMR rate
Time Frame:by 3, 6, 9, and 12 months of treatment.
Safety Issue:
Description:To compare MMR rate for the best response in patients within specific periods.
Measure:Complete Cytogenetic Response(CCyR) rate
Time Frame:by 3, 6, 9, and 12 months of treatment.
Safety Issue:
Description:To compare CCyR rate for the best response in patients within specific periods.
Measure:The MR 4.0 and MR 4.5 rates
Time Frame:by 3, 6, 9, and 12 months of treatment, and late
Safety Issue:
Description:To compare the MR4.0 and MR4.5 rates for the best response in patients within specific periods.
Measure:Disease progression (AP/BC) rate
Time Frame:at 3, 6, and 12 months
Safety Issue:
Description:To compare disease progression for the best response in patients within specific periods.
Measure:Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*)
Time Frame:at 3, 6, and 12 months
Safety Issue:
Description:To compare failure rate for the best response in patients within specific periods.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Il-Yang Pharm. Co., Ltd.

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