Status:
COMPLETED
Treatment of Adult Ph+ LAL With BMS-354825
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Lymphoblastic Leukemia, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed 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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00391989
Start Date
September 1 2006
End Date
September 1 2008
Last Update
January 4 2017
Active Locations (36)
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1
Ospedale San Donato USL 8
Arezzo, Arezzo, Italy
2
Università degli Studi di Bari
Bari, Bari, Italy
3
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Bologna, Italy
4
Azienda Spedali Civili
Brescia, Brescia, Italy