Stop dasatinib study (STDAST)

Phase 2

• Conditions: chronic myeloid leukemia-chronic phase; Chronic myeroid leukemia

• Registration Number: JPRN-jRCTs071180043
• Lead Sponsor: Akashi Koichi

Brief Summary

One-year CMR maintenance rate after discontinuation of dasatinib was about 60% in patients who obtained 2 year CMR by dasatinib treatment, and the same effect was maintained until 3 years thereafter. The CMR arrival rate after re-administration of dasatinib was 90.0% in recurrence after dasatinib discontinuation. No events were observed in either EFS or PFS. These results were almost the same as those of other TKIs. No fatal cases were observed, and no adverse events that cause major problems were observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Study Completion: 2019-12-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

1) CML-CP patients under treatment of imatinib, nilotinib or dasatinib
2) Patients without blast phase or accelerated phase CML
3) No extramedullary leukemia except hepatomegalia and splenoma
4) Patients with Ph+ or wild type in myeloid cytogenetics
5) Patients for CMR within 3 months before enrollment (Amp-CML: <5 copies/assay or PCR <=0.0032%)
6) Age >=16 years
7) ECOG performance status of 0-2
8) Laboratory test as follows
1. Albumin: >= lower limits of normal (LLN)
2. Total bilirubin: <= 3x upper limits of normal(ULN)
3. AST & ALT: <= 3xULN
4. Creatinine: <= 3xULN
5. Potassium: >= LLN
6. Magnesium: >= LLN
9) No pleural effusion in chest X-ray
10) SpO2 >=94%
11) Patient in compliance with the prescribed visit schedule
12) Written informed consent from the patient

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 QT prolongation 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
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