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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155411
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Shenzhen Second People's Hospital

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).

Condition or disease Intervention/treatment Phase
Dasatinib BCR-ABL Chronic Myeloid Leukemia Drug: Dasatinib Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic‐Phase Chronic Myeloid Leukemia (CML-CP)
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 1, 2022


Arm Intervention/treatment
Experimental: Dasatinib 70 mg Drug: Dasatinib
70 mg of Dasatinib orally daily for 12 months




Primary Outcome Measures :
  1. Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test [ Time Frame: 12 months ]
    Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%


Secondary Outcome Measures :
  1. Proportion of patients with MR 4.0 at 12 months. [ Time Frame: 12 months ]
    Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%

  2. Proportion of patients with MR 4.5 at 12 months. [ Time Frame: 12 months ]
    Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032%

  3. Proportion of patients with Complete cytogenetic response (CCyR) at 12 months [ Time Frame: 12 months ]
    defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%

  4. Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib [ Time Frame: 18 months ]
    Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155411


Contacts
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Contact: Xin Du 075583366388 duxingz@medmail.com.cn

Locations
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China, Guangdong
Xin Du Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Xin Du, PHD         
Sponsors and Collaborators
Shenzhen Second People's Hospital
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Responsible Party: Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT04155411    
Other Study ID Numbers: 20191103
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shenzhen Second People's Hospital:
Dasatinib, CML-CP
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action