A Phase II Study of BMS-354825 in Subjects with Lymphoid Blast Phase ChronicMyeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib MesylateRevised Protocol 01: Incorporates Amendment 03 and Administrative Letter 01, andAmendment 01 country specific version 1.0 dated 2005-03-14

• Conditions: ympohid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (ALL)

• Registration Number: EUCTR2004-002517-36-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

1)Subjects with Ph+ (or BCR/ABL+) lymphoid blast phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Subjects are considered to have lymphoid blast phase CML if they meet at least one of the following criteria:
•30% lymphoid blasts in peripheral blood or bone marrow
•Extramedullary infiltrates of leukemic cells (other than in spleen or liver) with peripheral blood lymphoid blast morphology.
OR
Subjects with Ph + ALL previously treated with standard induction or consolidation chemotherapy and progression or lack of response to imatinib at a dose > or equal to 600 mg/day (or 400 mg/day to < 600 mg/day if the subject is intolerant of 600 mg/day) after 4 weeks.
2)ECOG performance status score 0 - 2 (See Appendix 1)
3)Adequate hepatic function defined as:
•total bilirubin < or equal to 2.0 times the institutional upper limit of normal
•alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < or equal to 2.5 times the institutional upper limit of normal
4)Adequate renal function defined as:
•serum creatinine < or equal to 1.5 times the institutional upper normal limit
5)Serum potassium and magnesium levels within institutional normal limits. Total
serum calcium or ionized calcium level must be greater than or equal to the lower
limit of normal.
6)Men and women, 18 years of age or older.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Women who are pregnant or breastfeeding.
2) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least 1 month before and for at least 3 months after completion of the study medication.
3) Subjects who are eligible and willing to undergo transplantation during the screening period.
4) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
5) Uncontrolled or significant cardiovascular disease
6) Subjects who received:
- imatinib mesylate within 7 days
- interferon or cytarabine within 14 days
- a targeted small molecule anti-cancer agent within 14 days,
- any other investigational or antineoplastic agent other than hydroxyurea or anagrelide within 28 days before starting treatment with BMS-354825
7) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
8) Subjects taking medications that irreversibly inhibit platelet function
9) Prior therapy with BMS-354825.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified