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

Primary Purpose

Dasatinib, BCR-ABL, Chronic Myeloid Leukemia

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dasatinib

About this trial

This is an interventional treatment trial for Dasatinib focused on measuring Dasatinib, CML-CP

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Patients in late chronic phase (i.e. time from diagnosis to treatment >12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase are excluded.

Sites / Locations

Xin DuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dasatinib 70 mg

Arm Description

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Proportion of patients with MR 4.0 at 12 months.

Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%

Proportion of patients with MR 4.5 at 12 months.

Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032%

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

defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%

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

Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges

Full Information

NCT ID

NCT04155411

First Posted

November 5, 2019

Last Updated

July 26, 2022

Sponsor

Shenzhen Second People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04155411

Brief Title

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

Official Title

Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen Second People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

Detailed Description

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of 70mg dasatinib by measuring rates of major molecular response (MMR) at 12 months in patients with CML-CP in China. Approximately 65 Patients will be recruited consecutively from the study sites during the enrollment period and will be given dasatinib 70 mg QD. The duration of patient participation will be 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dasatinib, BCR-ABL, Chronic Myeloid Leukemia

Keywords

Dasatinib, CML-CP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dasatinib 70 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dasatinib

Intervention Description

70 mg of Dasatinib orally daily for 12 months

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Proportion of patients with MR 4.0 at 12 months.

Description

Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%

Time Frame

12 months

Title

Proportion of patients with MR 4.5 at 12 months.

Description

Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032%

Time Frame

12 months

Title

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

Description

defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%

Time Frame

12 months

Title

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

Description

Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Patients in late chronic phase (i.e. time from diagnosis to treatment >12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase are excluded.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xin Du

Phone

075583366388

duxingz@medmail.com.cn

Facility Information:

Facility Name

Xin Du

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Du, PHD

12. IPD Sharing Statement

Learn more about this trial

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

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