Clinical research of safety and efficacy after a stop of dasatinib administration in patients with chronic myeloid leukemia -chronic phase (CML-CP) achieving a complete molecular response (CMR) on a treatment of tyrosine kinase inhibitors (TKIs).

Phase 2

• Conditions: Chronic myeloid leukemia -chronic phase (CML-CP)

• Registration Number: JPRN-UMIN000008583
• Lead Sponsor: CML stem cell study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2019-10-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who attend other clinical trial. 2) BCR-ABL point mutation (T315I, F317L, V299L) 3) QTc interval prolongation (>450msec) 4) Patient who has clear pleural effusion 5) Patients who have the following cardiovascular dysfunction 1. Impossible to measure QT interval in ECG 2. Complete left bundle branch block 3. Internal pacemaker 4. Congenital long QT syndrome or family history 5. Tachycardia 6. Bradycardia (<50bpm) 7. Myocardial infarction within 6 months 8. Angina pectoris within 3 months 9. Congestive heart failure within 3 months 10. Patient who have the complications of cardiovascular disorder 6) Active double cancer 7) Pregnant or breastfeeding woman 8) Patient who have complications with serious or poor control 9) Mental disorder 10) Cognitive dysfunction 11) Patient who judges the investigator to have difficulty in participation in study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The CMR maintenance rate at 1 year after a stop of dasatinib administration in patient who have maintained CMR for 2 years in treatment of TKIs.

Secondary Outcome Measures

Name	Time	Method
* The CMR maintenance rate at 2 and 3 years ,and relapse free survival (RFS), event free survival (EFS) , progression free survival (PFS) and overall survival (OS) at 1, 2 and 3 years after a stop of dasatinib administration in patient who have maintained CMR for 2 years after a start of clinical study. *The 2 year CMR maintenance rate of patients at 24 months after the start of study. * The relationship between the time to CMR or MMR achievement and CMR maintenance rate at 1, 2 and 3 year after the stop of administration. * The search for predictive factor of a stop of dasatinib administration. * The relationship between the CMR maintenance rate and the following factors. - age, sex, Sokal score - treatment duration of TKIs - Total duration of BCR-ABL negative conversion to pre-registration. - LGL incidence - total treatment period and total dose of dasatinib * CMR achievement rate after re-administration in recurrent case after stop of dasatinib administration. * Safety