NCT04136015

Early Conversion of Dasatinib in CML-CP Patients

A Prospective Study on Early Conversion of Dasatinib in CML-CP Patients Who Have Not Early Molecular Response on Imatinib

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

Chronic myeloid leukemia (CML) is a malignant disease of acquired hematopoietic stem cells. The BCR-ABL fusion gene is the pathogenic basis of CML. Tyrosine kinase inhibitors (TKIs) are targeted drugs for this fusion protein. With the wide clinical application of TKIs, the efficacy of CML patients has been greatly improved. However, there are still a significant number of patients who have poor response to the first generation of TKI drugs, imatinib, most of them have early molecular response failures (BCR-ABL（IS）\>10% at 3 or 6 months) ，which means lower rates of molecular response, increased risk of progression, and higher overall survival. For them, the early conversion of dasatinib might be a better choice.

Conditions

• Validity and Safety

Interventions

Type	Name	Description
DRUG	Dasatinib 100 MG	The CML-CP patients with early(3m to 6m) molecular response failure on imatinib,Conversion dasatinib group or Imatinib group

Timeline

• Start date: 2019-10-22
• Primary completion: 2021-12-01
• Completion: 2021-12-31
• First posted: 2019-10-23
• Last updated: 2020-12-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study