Clinical Trials /

Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

NCT03216070

Description:

Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
  • Official Title: Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: HE17 00004
  • NCT ID: NCT03216070

Conditions

  • Chronic Myelogenous Leukemia

Interventions

DrugSynonymsArms
Dasatinib 50 MGSprycelArm1 Low Dose Dasatinib

Purpose

Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.

Detailed Description

      We will give 50mg of dasatinib daily since the diagnosis for up to 6 months, for the first
      2-4 weeks we will evaluate hematic biometry to registry hematic response, at months 3 and 6 a
      BCR/ABL PCR will be taken to evaluate molecular response.
    

Trial Arms

NameTypeDescriptionInterventions
Arm1 Low Dose DasatinibExperimentalWe will give 50mg of dasatinib orally daily for 6 months
  • Dasatinib 50 MG

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of BCR-ABL positive CML in early chronic phase CML. Except for hydroxyurea,
             patients must have received no or minimal prior therapy, defined as <2 weeks (14 days)
             of prior FDA approved TKI.

          -  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 indicating they are aware of the
             investigational nature of this study.

        Exclusion Criteria:

          -  NYHA cardiac class 3-4 heart disease or previous pleural effusion.

          -  Pregnancy and lactation

          -  Patients with active, uncontrolled psychiatric disorders
      
Maximum Eligible Age:N/A
Minimum Eligible Age:16 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Molecular Response at 6 months
Time Frame:6 months
Safety Issue:
Description:Molecular Response define as BCR/ABL <1%

Secondary Outcome Measures

Measure:Early Molecular Response at 3 and 6 months
Time Frame:3 and 6 months
Safety Issue:
Description:Early Molecular Response define as <10%

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hospital Universitario Dr. Jose E. Gonzalez

Trial Keywords

  • Dasatinib

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