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

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Unknown; Phase 4

Conditions: Chronic Myelogenous Leukemia

Treatments: Drug: Dasatinib 50 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03216070

HE17 00004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Arm1 Low Dose Dasatinib

Experimental group

Description:

We will give 50mg of dasatinib orally daily for 6 months

Treatment:

Drug: Dasatinib 50 MG