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

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.

Study Overview

• Status: Unknown
• Conditions: Validity and Safety
• Intervention / Treatment: Drug: Dasatinib 100 MG

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • NanfangH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

CML-CP patients treated with imatinib failed to achieve the best therapeutic effect（BCR/ABLIS>10.00% in 3m or BCR/ABLIS>1.00% in 6m）convert to dasatinib.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: TKIs-cml-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No