Early Conversion of Dasatinib in CML-CP Patients

NCT04136015 | Unknown FDA Drug

• 1 other identifier: TKIs-cml-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Validity and Safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dasatinib group

Drug: Dasatinib 100 MG

Imatinib group

Drug: Dasatinib 100 MG

Interventions

Dasatinib 100 MG DRUG

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

Dasatinib group; Imatinib group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• History of CML-CP or CML-AP;
• Resistant to dasatinib,or treatment with imatinib more than 6 months;
• Received allogeneic hematopoietic stem cell transplantation,or immunotherapy;
• woman who is pregnant or nursing
• Combined with other serious organic diseases, serious arrhythmia, pulmonary hypertension, cardiomyopathy, serious autoimmune diseases.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanfangH

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Interventions

Dasatinib

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: October 22, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)