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

Chronic Myeloid Leukemia, Chronic Phase Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03722420
• Other study ID #: RT51CN03
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 28, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: June 30, 2025
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

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).
• Imatinib
Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.

Locations

Country	Name	City	State
China	Peking University People's Hospital(????????)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The MMR rate	The MMR rate at 12 months after radotinib or imatinib treatment in patients with newly diagnosed CML-CP.	at 12 months after radotinib or imatinib treatment
Secondary	MMR rate	To compare MMR rate for the best response in patients within specific periods.	by 3, 6, 9, and 12 months of treatment.
Secondary	Complete Cytogenetic Response(CCyR) rate	To compare CCyR rate for the best response in patients within specific periods.	by 3, 6, 9, and 12 months of treatment.
Secondary	The MR 4.0 and MR 4.5 rates	To compare the MR4.0 and MR4.5 rates for the best response in patients within specific periods.	by 3, 6, 9, and 12 months of treatment, and late
Secondary	Disease progression (AP/BC) rate	To compare disease progression for the best response in patients within specific periods.	at 3, 6, and 12 months
Secondary	Failure rate according to European Leukemia Net (ELN) guideline 2013 (ELN 2013*)	To compare failure rate for the best response in patients within specific periods.	at 3, 6, and 12 months