Chronic Myelogenous Leukemia
Conditions
Keywords
Dasatinib
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.
Interventions
DRUGDasatinib 50 MG
50mg of dasatinib orally daily
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecular Response at 6 months | 6 months | Molecular Response define as BCR/ABL \<1% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Molecular Response at 3 and 6 months | 3 and 6 months | Early Molecular Response define as \<10% |
Countries
Mexico
Contacts
Primary ContactDavid Gomez, MD
Outcome results
None listed