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

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ClinicalTrials.gov Identifier: NCT03216070
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia Drug: Dasatinib 50 MG Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018


Arms and Interventions

Arm Intervention/treatment
Experimental: Arm1 Low Dose Dasatinib
We will give 50mg of dasatinib orally daily for 6 months
Drug: Dasatinib 50 MG
50mg of dasatinib orally daily
Other Name: Sprycel


Outcome Measures

Primary Outcome Measures :
  1. Molecular Response at 6 months [ Time Frame: 6 months ]
    Molecular Response define as BCR/ABL <1%


Secondary Outcome Measures :
  1. Early Molecular Response at 3 and 6 months [ Time Frame: 3 and 6 months ]
    Early Molecular Response define as <10%


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT03216070


Contacts
Contact: David Gomez, MD 52 81 8348-8510 dr_gomez@infosel.net.mx

Locations
Mexico
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: David Gomez-Almaguer, MD    +52 81 8348-8510    dr_gomez@infosel.net.mx   
Contact: Paola Santana, MD    +52 664 3864975    paola_santana72@hotmail.com   
Principal Investigator: David Gomez-Almaguer, MD         
Sub-Investigator: Manuel Solano, MD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
More Information

Publications:

Responsible Party: Dra. Olga Graciela Cantu Rodriguez, MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03216070     History of Changes
Other Study ID Numbers: HE17 00004
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dra. Olga Graciela Cantu Rodriguez, Hospital Universitario Dr. Jose E. Gonzalez:
Dasatinib

Additional relevant MeSH terms:
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