Dose Reduced Dasatinib (70 mg Daily) as First-line Treatment for Newly Diagnosed CML-CP

NCT04155411 | Unknown Phase 4

• 1 other identifier: 20191103
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).

Conditions

Dasatinib; BCR-ABL; Chronic Myeloid Leukemia

Keywords

Dasatinib, CML-CP

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test

  Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%

  12 months

Secondary Outcomes (4)

• Proportion of patients with MR 4.0 at 12 months.

  12 months

• Proportion of patients with MR 4.5 at 12 months.

  12 months

• Proportion of patients with Complete cytogenetic response (CCyR) at 12 months

  12 months

• Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib

  18 months

Study Arms (1)

Dasatinib 70 mg

EXPERIMENTAL

Drug: Dasatinib

Interventions

Dasatinib DRUG

70 mg of Dasatinib orally daily for 12 months

Dasatinib 70 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months.
• ECOG performance of 0-2.
• Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
• Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital

You may not qualify if:

• History of any TKI treatments.
• History of Pulmonary arterial hypertension and Pleural effusion
• NYHA cardiac class 3-4 heart disease.
• Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist:
• Uncontrolled angina within 12 months.
• Diagnosed or suspected congenital long QT syndrome.
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
• Prolonged QTc interval on pre-entry electrocardiogram (\>450 msec).
• Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
• Women of pregnancy potential must practice an effective method of birth control, unless otherwise instructed, during the course of the study in a manner such that risk of failure is minimized.
• Pregnant or breast-feeding women are excluded.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Xin Du

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Xin Du

CONTACT

075583366388; duxingz@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-06

Locations

CN (1)