Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
This study is currently recruiting participants.
Verified December 2012 by Il-Yang Pharm. Co., Ltd.
Sponsor:
Il-Yang Pharm. Co., Ltd.
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01511289
First received: January 3, 2012
Last updated: December 27, 2012
Last verified: December 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Bone Marrow Diseases Hematologic Diseases |
Drug: Imatinib Drug: Radotinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Il-Yang Pharm. Co., Ltd.:
Primary Outcome Measures:
- Rate of Major Molecular Response(MMR) by 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 month ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]Disease progression by month 12 will be compared between each groups.
| Estimated Enrollment: | 240 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Imatinib |
Drug: Imatinib
400mg/Tab, QD
Other Names:
|
|
Experimental: Radotinib 300mg
Radotinib 300mg BID
|
Drug: Radotinib
100mg or 200mg/Capsule, 300mg or 400mg BID
Other Name: IY5511HCl
|
|
Experimental: Radotinib 400mg
Radotinib 400mg BID
|
Drug: Radotinib
100mg or 200mg/Capsule, 300mg or 400mg BID
Other Name: IY5511HCl
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511289
Contacts
| Contact: IL-YANG PHARM | 82 31 281 7851 |
Locations
| India | |
| Local Institution | Not yet recruiting |
| Mumbai, India | |
| Local Institution | Not yet recruiting |
| New Delhi, India | |
| Indonesia | |
| Local Institution | Not yet recruiting |
| Jakarta, Indonesia | |
| Korea, Republic of | |
| Local Institution | Recruiting |
| Busan, Korea, Republic of, 602-739 | |
| Local Institution | Recruiting |
| Busan, Korea, Republic of, 602-715 | |
| Local Institution | Recruiting |
| Daegu, Korea, Republic of, 700-712 | |
| Local Institution | Recruiting |
| Gyeonggi-do, Korea, Republic of, 431-070 | |
| Local Institution | Recruiting |
| Gyeonggi-do, Korea, Republic of, 443-721 | |
| Local Institution | Recruiting |
| Gyeonggi-do, Korea, Republic of, 442-723 | |
| Local Institution | Recruiting |
| Jeollabuk-do, Korea, Republic of, 561-712 | |
| Local Institution | Recruiting |
| Jeonnam, Korea, Republic of, 519-763 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 110-746 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 158-710 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 152-703 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Local Institution | Recruiting |
| Ulsan, Korea, Republic of, 682-714 | |
| Philippines | |
| Local Institution | Not yet recruiting |
| Manilla, Philippines | |
| Thailand | |
| Local Institution | Not yet recruiting |
| Bangkok, Thailand | |
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
| Study Director: | IL-YANG PHARM | IL-YANG Pharmaceutical. Co., LTD |
More Information
No publications provided
| Responsible Party: | Il-Yang Pharm. Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01511289 History of Changes |
| Other Study ID Numbers: | IY5511A3001 |
| Study First Received: | January 3, 2012 |
| Last Updated: | December 27, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) Indonesia: The National Agency of Drug and Food Control (NA-DFC) Philippines: Bureau of Food and Drugs Thailand: Ethical Committee |
Keywords provided by Il-Yang Pharm. Co., Ltd.:
|
Radotinib CML-CP Chronic Myeloid Leukemia, chronic phase |
Additional relevant MeSH terms:
|
Bone Marrow Diseases Hematologic Diseases Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Translocation, Genetic |
Chromosome Aberrations Pathologic Processes Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013