Treatment of Adult Ph+ LAL With BMS-354825

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status and phase

Completed

Phase 2

Conditions

Lymphoblastic Leukemia, Acute

Treatments

Drug: Dasatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT00391989

LAL1205

Details and patient eligibility

About

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.

Full description

This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.