Treatment of Adult Ph+ LAL With BMS-354825

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.

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

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Dasatinib

Criteria

Inclusion Criteria:

• Patients with Ph+ and/or BCR/ABL+ ALL

• Age ≥18 years old

• De novo ALL (within 14 days from diagnosis)

• No prior treatment with any anti-leukemic drugs with the exception of steroids for no more than 14 days (including the 7-day pretreatment already scheduled in the protocol)

• WHO performance status ≤2

• Absence of central nervous system (CNS) leukemia

• Normal serum level of potassium, total calcium corrected for serum albumin magnesium and phosphorus, or correctable with supplements

• ALT and AST ≤2.5 x ULN or ≤5.0 x ULN if considered due to leukemia

• Alkaline phosphatase ≤2.5 x ULN unless considered to leukemia

• Serum bilirubin ≤2 x ULN

• Serum creatinine ≤3 x ULN

• Serum amylase ≤1.5 x ULN and serum lipase ≤1.5 x ULN

• Normal cardiac function

• Written informed consent prior to any study procedures being performed.

Exclusion Criteria:

• Impaired cardiac function, including any one of the following:

• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BMS-354825 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)

• Use of therapeutic warfarin

• Acute or chronic liver or renal disease considered unrelated to leukemia

• Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol

• Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM¬CSF) ≤1 week prior to starting study drug

• Patients who are currently receiving treatment with any of the medications listed in "Appendix F" and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in "Appendix F" have the potential to prolong the QT interval.

• Patients who have received any anti-leukemic agents and treatments including steroids for more than 14 days including 7 days pretreatment that is part of the protocol

• Patients who have received any investigational drug in the last 2 weeks

• Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy

• Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of BMS-354825). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

• Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)

• Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention

• Non compliant to oral medication patients.