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.
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.
Unknown status
Phase 4
Drug | Synonyms | Arms |
---|---|---|
Dasatinib 50 MG | Sprycel | Arm1 Low Dose Dasatinib |
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.
Name | Type | Description | Interventions |
---|---|---|---|
Arm1 Low Dose Dasatinib | Experimental | We will give 50mg of dasatinib orally daily for 6 months |
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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 |
Measure: | Molecular Response at 6 months |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Molecular Response define as BCR/ABL <1% |
Measure: | Early Molecular Response at 3 and 6 months |
Time Frame: | 3 and 6 months |
Safety Issue: | |
Description: | Early Molecular Response define as <10% |
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Hospital Universitario Dr. Jose E. Gonzalez |
July 13, 2017