First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The main aim of the present study is to evaluate the clinical efficacy of first-line dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic leukemia. In this study, the investigators will analyze the clinical outcomes for entire patient population as well as those for transplants, respectively. In addition, the results of this study will be compared to those of the investigators current study (imatinib plus conventional chemotherapy). The safety of this treatment will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Catholic University of Korea
• Treatments: BB 1101; Cyclophosphamide; Cytarabine; Dasatinib; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Mitoxantrone; Vincristine

Criteria

Inclusion Criteria:

• Patients with newly diagnosed acute lymphoblastic or biphenotypic leukemia (karyotypic or molecular evidence of Ph)

• Ages of 15-65 years

• Eastern Cooperative Oncology Group performance status of 0-2

• Adequate renal (serum creatinine less than 2 mg/dl, unless considered due to leukemia) and hepatic (serum bilirubin less than 3 mg/dl, unless considered due to leukemia) functions

• Adequate cardiac status (New York Heart Association Class less than or equal to 2)

• Signed informed consent

Exclusion Criteria:

• Pregnant and lactating women will not be eligible. Women of childbearing potential should have a negative pregnancy test prior to entering on the study.

• Active cardiac dysfunction (New York Heart Association Class more than or equal to 3), uncontrolled angina, myocardial infarction (within 6 months), congenital long QT syndrome, any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia or ventricular fibrillation), or prolonged QTc interval on pre-entry electrocardiogram (more than 470 msec)

• Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia

• Patients with severe medical conditions that in the view of the investigator prohibits participation in the study

• Treatment with any other investigational antileukemic agents in the last 30 days before study entry