Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
- Registration Number
- NCT03216070
- Lead Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm1 Low Dose Dasatinib Dasatinib 50 MG We will give 50mg of dasatinib orally daily for 6 months
- Primary Outcome Measures
Name Time Method Molecular Response at 6 months 6 months Molecular Response define as BCR/ABL \<1%
- Secondary Outcome Measures
Name Time Method Early Molecular Response at 3 and 6 months 3 and 6 months Early Molecular Response define as \<10%
Trial Locations
- Locations (1)
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
🇲🇽Monterrey, Nuevo Leon, Mexico