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

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: Dasatinib

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