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

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ClinicalTrials.gov Identifier: NCT03722420
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia, Chronic Phase Drug: Radotinib Drug: Imatinib Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel, 2 arms
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: Radotinib 300mg
Oral adminstration of Radotinib 300mg BID (600mg/day) for 12months
Drug: Radotinib
Patients randomized to the radotinib arms will receive 300 mg of radotinib BID (1 in the morning and 1 in the evening, at approximately 12-hour intervals).
Other Name: Supect

Active Comparator: Imatinib 400mg
Oral administration of Imatinib 400mg QD (400mg/day) for 12months
Drug: Imatinib
Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.
Other Name: Glivec




Primary Outcome Measures :
  1. The MMR rate [ Time Frame: at 12 months after radotinib or imatinib treatment ]
    The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.


Secondary Outcome Measures :
  1. MMR rate [ Time Frame: by 3, 6, 9, and 12 months of treatment. ]
    To compare MMR rate for the best response in patients within specific periods.

  2. Complete Cytogenetic Response(CCyR) rate [ Time Frame: by 3, 6, 9, and 12 months of treatment. ]
    To compare CCyR rate for the best response in patients within specific periods.

  3. The MR 4.0 and MR 4.5 rates [ Time Frame: by 3, 6, 9, and 12 months of treatment, and late ]
    To compare the MR4.0 and MR4.5 rates for the best response in patients within specific periods.

  4. Disease progression (AP/BC) rate [ Time Frame: at 3, 6, and 12 months ]
    To compare disease progression for the best response in patients within specific periods.

  5. Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*) [ Time Frame: at 3, 6, and 12 months ]
    To compare failure rate for the best response in patients within specific periods.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722420


Contacts
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Contact: Jeong H Kim +82.70.7165.7318 jhkim6@ilyang.co.kr
Contact: Bo Hwangbo +82.70.7165.7320 buhwang@ilyang.co.kr

Locations
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China
Peking University People's Hospital(北京大学人民医院) Recruiting
Beijing, China, 100044
Contact: Jiang Qian         
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
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Principal Investigator: Jiang Qian Peking University People's Hospital(北京大学人民医院)

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Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03722420     History of Changes
Other Study ID Numbers: RT51CN03
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action