Leukemia, Myelogenous, Chronic, BCR-ABL Positive Clinical Trial
Official title:
Extension Study of a Study to Evaluate Efficacy and Safety of Imatinib (Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase
This study is an extension study (prospective observational study) of 'IDEAL' study (A Study to Evaluate Efficacy and Safety of Imatinib (Glinib) 600mg/day depending on Early Molecular Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase, NCT02204722) to evaluate the duration of treatment response, disease progression, and survival status up to 5 years after the inclusion.
We have started a prospective study of evaluating efficacy and safety of imatinib 600mg/day depending on early molecular response in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (IDEAL, NCT02204722), which will enroll 150 patients and follow up them for 1 years for the purpose of evaluating the primary endpoints - difference of major molecular response rate at 1 year. However, Chronic myelogenous is a disease which needs long-term for the outcome of treatment with BCR-ABL tyrosine kinase inhibitor. After the end of follow-up period of IDEAL study, subjects who agree with this extension study (IDEAL-E) will be enrolled and be followed up for additional 4 years to evaluate the duration of treatment response, disease progression, and survival status. Subjects who will be enrolled in this prospective observational study will be treated with drugs - imatinib 300-600mg / nilotinib 600mg / dasatinib 100mg - which has been chosen by the each investigator according to the drug compliance and overall response. The drug choice will be at the discretion of each investigator, and the overall adverse event / molecular response will be monitored every 6 months in this prospective observational study. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01437202 -
Pharmacogenomics Validation for Imatinib in Chronic Myeloid Leukemia
|
N/A | |
Completed |
NCT02896842 -
A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CML
|
Phase 2 | |
Completed |
NCT01768689 -
Interventional Study to Improve Adherence to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
|
N/A | |
Not yet recruiting |
NCT02903277 -
National Observatory of Chronic Myeloid Leukemia Adolescent and Young Adults Treated With Tyrosine Kinase Inhibitors in First Intent
|
N/A | |
Completed |
NCT03090477 -
Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients
|
N/A | |
Active, not recruiting |
NCT02885766 -
Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for Oral Administration in Adults With Ph+ Chronic Myeloid Leukemia, Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
|
Phase 1/Phase 2 | |
Recruiting |
NCT01464411 -
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
|
N/A | |
Completed |
NCT01602952 -
Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT02687425 -
Safety and Efficiency Study of Pioglitazone in Combination With Imatinib Mesylate to Treat Chronic Myelogenous Leukemia
|
Phase 2 | |
Completed |
NCT00171223 -
An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
|
Phase 2 | |
Recruiting |
NCT04877522 -
Asciminib Roll-over Study
|
Phase 4 | |
Completed |
NCT01511289 -
Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
|
Phase 3 | |
Completed |
NCT02480608 -
Treatment of CML Patients With Imatinib and Hydroxyurea (CML2004)
|
Phase 1/Phase 2 | |
Completed |
NCT02389972 -
Effectiveness of Dasatinib in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
|
N/A | |
Completed |
NCT01774630 -
Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2)
|
Phase 2 |