Phase II Clinical Trial of Dasatinib Therapy Aiming for Treatment-Free Remission in Patients with Chronic Phase Chronic Myeloid Leukemia

Phase 2

• Conditions: Chronic Phase Chronic Myeloid Leukemia

• Registration Number: JPRN-UMIN000022254
• Lead Sponsor: Kanto CML Study Group

Brief Summary

The study examined whether CML-CP patients (pts) treated with dasatinib (DAS) for <=3 years (yrs) and maintained MR4.5 for exactly 1 year (yr) would achieve TFR if DAS was discontinued. Of the first 21 pts who discontinued, 17 developed molecular relapse. The median duration of treatment with DAS before cessation was 18.9 months, which was shorter than previously reported. These results indicate that maintaining MR4.5 for 1 yr is not sufficient to achieve TFR in CML-CP pts treated with DAS for <= 3 yrs.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-21
• Study Completion: 2021-12-03
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

Not provided

Exclusion Criteria

1)Active multiple cancers 2)Pregnant women and lactating mothers 3)Women who do not intend to or cannot use appropriate contraceptives during the registration period 4)Patients with a history or complications of the following severe or uncontrollable symptoms Myocardial infarction within the past 6 months Angina pectoris within the past 3 months Gastrointestinal haemorrhage within the past 3 months Congestive cardiac failure within the past 3 months Having plural effusion Electrocardiogram QTc interval prolonged exceeding 450 msec at the start of treatment (baseline) (Fridericia correction) Present or past history of pulmonary hypertension 5)Patients with a history or complications of diseases judged as inappropriate for study implementation by investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients in TFR who show no molecular relapse and do not need resumption of dasatinib treatment 12 months after discontinuation of dasatinib treatment

Secondary Outcome Measures

Name	Time	Method
Percentage of patients in TFR 24, 36, and 48 months after discontinuation of dasatinib treatment. Molecular relapse free survival 12 months after discontinuation of dasatinib treatment Overall survival (OS) including all causes of death 12, 24, 36, and 48 months after discontinuation of dasatinib treatment Dasatinib doses and time to MR4.5 Event free survival (EFS) during dasatinib treatment period. Frequency and degree of TKI withdrawal syndrome after discontinuation of dasatinib treatment.