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A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-positive

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Trial Information

A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate


Inclusion Criteria:



- Subjects with Philadelphia chromosome positive (Ph+) (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 who 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.

- ECOG performance status score 0-2.

- Adequate hepatic function defined as: *Total bilirubin less than or equal to 2.0
times the institutional upper limit of normal; *alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) less than or equal to 2.5 times the institutional
upper limit of normal.

- Adequate renal function defined as: *serum creatinine less than or equal to 1.5 times
the institutional upper normal limit.

- Men and women, 18 years of age or older.

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of at least 1
month before and at least 3 months after the study in such a manner that the risk of
pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test
(minimum sensitivity 25 IC/L or equivalent units of HCG) within 72 hours prior to the
start of study medication.

Exclusion Criteria:

- 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.

- WOCBP using a prohibited contraceptive method (not applicable).

- Women who are pregnant or breastfeeding.

- Women with a positive pregnancy test on enrollment or prior to study drug
administration.

- Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable
method to avoid pregnancy of his partner for the entire study period and for at least
3 months after completion of study medication.

- Subjects who are eligible and willing to undergo transplantation during the screening
period.

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy.

- Demential or altered mental status that would prohibit the understanding or rendering
of informed consent.

- History of significant bleeding disorder unrelated to CML.

- Concurrent incurable malignancy other than CML.

- Evidence of organ dysfunction or digestive dysfunction that would prevent
administration of study therapy.

- Subjects who received any of the following:

- 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.

- Subjects currently taking drugs that are generally accepted to have a risk of causing
Torsades de Pointes.

- Subjects taking medications that irreversibly inhibit platelet function.

- Prior therapy with BMS-354825.

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Major and overall hematologic response rates

Outcome Time Frame:

throughout the study

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-015

NCT ID:

NCT00101595

Start Date:

January 2005

Completion Date:

December 2007

Related Keywords:

  • Chronic Myeloid Leukemia
  • Leukemia, Lymphoblastic, Acute, Philadelphia-positive
  • Lymphoid blast phase chronic myeloid leukemia
  • Philadelphia chromosome positive acute lymphoblastic leukemia
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

Local InstitutionChicago, Illinois  
Local InstitutionBronx, New York  
Local InstitutionPortland, Oregon  
Local InstitutionBirmingham, Alabama  
Local InstitutionCorona, California  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionChattanooga, Tennessee  
Local InstitutionColumbia, Missouri