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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04136015

Enrollment

200

Registered

2019-10-23

Start date

2019-10-22

Completion date

2021-12-31

Last updated

2020-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validity and Safety

Brief 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.

Interventions

DRUGDasatinib 100 MG

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

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
MMR in 1 year	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026