Early Conversion of Dasatinib in CML-CP Patients

Validity and Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04136015
• Other study ID #: TKIs-cml-001
• Status: Enrolling by invitation
• Start date: October 22, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1.18-65 years old; 2.CML-CP,and Imatinib treatment longest for 6 months ; 3.Q-pcr monitoring of BCR/ABLIS failed to achieve the best therapeutic effect(BCR/ABLIS>10.00% in 3m or BCR/ABLIS>1.00% in 6m); 4.No previous history of malignant tumor; 5.Informed consent of the patient or his legal representative

Exclusion Criteria:

1. History of CML-CP or CML-AP;

2. Resistant to dasatinib,or treatment with imatinib more than 6 months;

3. Received allogeneic hematopoietic stem cell transplantation,or immunotherapy;

4. woman who is pregnant or nursing

5. Combined with other serious organic diseases, serious arrhythmia, pulmonary hypertension, cardiomyopathy, serious autoimmune diseases.

Related Conditions & MeSH terms

• Validity and Safety

Intervention

Drug:
• Dasatinib 100 MG
The CML-CP patients with early(3m to 6m) molecular response failure on imatinib,Conversion dasatinib group or Imatinib group

Locations

Country	Name	City	State
China	NanfangH	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMR in 1 year	MMR(BCR/ABL(IS)<0.1%) at 12 months after switching to dasatinib for patients who did not achieve optimal treatment with imatinib for 3 to 6 months.	1 year