NCT04150471

Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients

An Open Label, Observational Clinical Study to Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Any Grade of Adverse Events and Early Molecular Response Within 3 Months of Frontline Dasatinib Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 79 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (\< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Subjects will be allocated to 80mg QD based on EMR (Early Molecular Response) achievement and early safety profile following a standard of care approach.

Detailed description

Patients will sign the consent forms for screening prior to frontline dasatinib therapy (1st) and the 3 month molecular test date (2nd). The molecular samples will be analyzed in the central lab as part of the screening procedure. Subjects will be treated for a maximum of 60 months after allocation of the last subject on the assigned regimen (dasatinib 80mg QD), unless disease progression, treatment failure or unacceptable toxicity occurs, the subject withdraws consent, or the study is discontinued by the sponsor. Subjects who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years after allocation of the last subject. All subjects will be followed yearly for progression-free survival and overall survival. For patients who continue their assigned treatment, safety assessments will be conducted every 6 months and cytogenetic assessment as investigator assessment. Follow up visits after the last dose of study drug will be required at least every 4 weeks until all study related toxicities resolve to baseline (or CTC Grade ≤ 1), stabilize or are deemed irreversible.

Conditions

• Chronic Myelocytic Leukemia

Interventions

Type	Name	Description
OTHER	RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis	Conventional Q-RT-PCR every 3 months

Timeline

• Start date: 2018-10-18
• Primary completion: 2020-12-30
• Completion: 2023-12-30
• First posted: 2019-11-04
• Last updated: 2019-11-04

Locations

1 site across 1 country: South Korea