search
Back to results

Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Imatinib
Radotinib
Sponsored by
Il-Yang Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Radotinib, CML-CP, Chronic Myeloid Leukemia, chronic phase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with confirmed diagnosis of chronic phase CML within last 3 months
  • Patients with cytogenetically confirmed Ph positive CML in early chronic phase

Exclusion Criteria:

  • Patients with Philadelphia chromosome negative but BCR-ABL positive CML
  • Patients who used imatinib for 8 days or longer before study entry
  • Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
  • Patients with impaired cardiac function
  • Cytologically confirmed CNS involvement
  • Severe or uncontrolled chronic medical condition
  • Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia
  • Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Imatinib

Radotinib 600mg

Radotinib 800mg

Arm Description

Imatinib 400mg QD

Radotinib 300mg BID

Radotinib 400mg BID

Outcomes

Primary Outcome Measures

Rate of Major Molecular Response(MMR) by 12 months
Rate of Major Molecular Response (MMR) at Any Time within 12 months. MMR by 12 months will be assessed as responder if the patient has response at any time within 12 months. A major molecular response rate is defined as the ratio (%) of BCR-ABL/ABL ≤ 0.1% by international scale or a 3-log reduction in BCR-ABL transcript level from standardized baseline, as measured by standardized RQ-PCR assay.

Secondary Outcome Measures

Rate of complete cytogenetic response (CCyR) by 12 months
Complete cytogenetic response is defined as complete disappearance of Philadelphia-positive in at least 20 metaphases examined. Chromosome analysis performed on less than 20 metaphases will not be accepted for this study
Rate of complete molecular response (CMR) by 12 months
Complete molecular response is defined as negative BCR-ABL transcript levels, as measured twice by the internationally standardized RQ-PCR assay. The rate of complete molecular response by cycle 12 is defined as an at least 4.5 log reduction in BCR-ABL transcript levels from standardized baseline or BCR-ABL/ABL % ≤ 0.005% by the international scale.
Rate of major molecular response (MMR) at 12 months
Rate of Major Molecular response will be assessed at 12 months at that timepoint. Number of Participants With Major Molecular Response (MMR) at 12 months.
Rate of subjects with disease progression
Disease progression by month 12 will be compared between each groups.

Full Information

First Posted
January 3, 2012
Last Updated
February 22, 2016
Sponsor
Il-Yang Pharm. Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01511289
Brief Title
Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
Official Title
A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Il-Yang Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome, Bone Marrow Diseases, Hematologic Diseases
Keywords
Radotinib, CML-CP, Chronic Myeloid Leukemia, chronic phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imatinib
Arm Type
Active Comparator
Arm Description
Imatinib 400mg QD
Arm Title
Radotinib 600mg
Arm Type
Experimental
Arm Description
Radotinib 300mg BID
Arm Title
Radotinib 800mg
Arm Type
Experimental
Arm Description
Radotinib 400mg BID
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Glivec, Gleevec
Intervention Description
400mg/Tab, QD
Intervention Type
Drug
Intervention Name(s)
Radotinib
Other Intervention Name(s)
IY5511HCl
Intervention Description
100mg or 200mg/Capsule, 300mg or 400mg BID
Primary Outcome Measure Information:
Title
Rate of Major Molecular Response(MMR) by 12 months
Description
Rate of Major Molecular Response (MMR) at Any Time within 12 months. MMR by 12 months will be assessed as responder if the patient has response at any time within 12 months. A major molecular response rate is defined as the ratio (%) of BCR-ABL/ABL ≤ 0.1% by international scale or a 3-log reduction in BCR-ABL transcript level from standardized baseline, as measured by standardized RQ-PCR assay.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of complete cytogenetic response (CCyR) by 12 months
Description
Complete cytogenetic response is defined as complete disappearance of Philadelphia-positive in at least 20 metaphases examined. Chromosome analysis performed on less than 20 metaphases will not be accepted for this study
Time Frame
12 months
Title
Rate of complete molecular response (CMR) by 12 months
Description
Complete molecular response is defined as negative BCR-ABL transcript levels, as measured twice by the internationally standardized RQ-PCR assay. The rate of complete molecular response by cycle 12 is defined as an at least 4.5 log reduction in BCR-ABL transcript levels from standardized baseline or BCR-ABL/ABL % ≤ 0.005% by the international scale.
Time Frame
12 months
Title
Rate of major molecular response (MMR) at 12 months
Description
Rate of Major Molecular response will be assessed at 12 months at that timepoint. Number of Participants With Major Molecular Response (MMR) at 12 months.
Time Frame
12 month
Title
Rate of subjects with disease progression
Description
Disease progression by month 12 will be compared between each groups.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with confirmed diagnosis of chronic phase CML within last 3 months Patients with cytogenetically confirmed Ph positive CML in early chronic phase Exclusion Criteria: Patients with Philadelphia chromosome negative but BCR-ABL positive CML Patients who used imatinib for 8 days or longer before study entry Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells Patients with impaired cardiac function Cytologically confirmed CNS involvement Severe or uncontrolled chronic medical condition Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IL-YANG PHARM
Organizational Affiliation
IL-YANG Pharmaceutical. Co., LTD
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Jakarta
Country
Indonesia
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
633-165
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Local Institution
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Local Institution
City
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Local Institution
City
Jeonnam
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of
Facility Name
Local Institution
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Batangas
Country
Philippines
Facility Name
Local Institution
City
Manilla
Country
Philippines
Facility Name
Local Institution
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
28939746
Citation
Kwak JY, Kim SH, Oh SJ, Zang DY, Kim H, Kim JA, Do YR, Kim HJ, Park JS, Choi CW, Lee WS, Mun YC, Kong JH, Chung JS, Shin HJ, Kim DY, Park J, Jung CW, Bunworasate U, Comia NS, Jootar S, Reksodiputro AH, Caguioa PB, Lee SE, Kim DW. Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Clin Cancer Res. 2017 Dec 1;23(23):7180-7188. doi: 10.1158/1078-0432.CCR-17-0957. Epub 2017 Sep 22.
Results Reference
derived

Learn more about this trial

Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients

We'll reach out to this number within 24 hrs