Know Cancer

forgot password

A Phase II Multicenter Study on the Treatment of Adult de Novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) With the Protein Tyrosine Kinase Inhibitor BMS-354825. EudraCT Number 2005-005107-42.

Phase 2
18 Years
Not Enrolling
Lymphoblastic Leukemia, Acute

Thank you

Trial Information

A Phase II Multicenter Study on the Treatment of Adult de Novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) With the Protein Tyrosine Kinase Inhibitor BMS-354825. EudraCT Number 2005-005107-42.

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

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

- 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

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

- Non compliant to oral medication patients.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of hematological complete remission (HCR)obtained during the BMS induction treatment within day +85 from the start of BMS (i.e., whenever achieved from the start of the experimental drug).

Principal Investigator

Robin Foà, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Università degli Studi di Roma "La Sapienza", Dipartimento di Biotecnologie Cellulari ed Ematolgia


Italy: The Italian Medicines Agency

Study ID:




Start Date:

September 2006

Completion Date:

September 2008

Related Keywords:

  • Lymphoblastic Leukemia, Acute
  • Ph+ Acute Lymphoblastic Leukaemia
  • Dasatinib
  • targeted therapy
  • Patients with Ph positive and or BCR ABL positive ALL
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome
  • Acute Disease