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A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment


Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Both
Chronic Myelogenous Leukemia

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Trial Information

A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment


Inclusion Criteria:



- Philadelphia chromosome positive or bcr-abl gene positive

- Chronic Myelogenous Leukemia (CML)

- Subjects must have primary or acquired resistance to imatinib mesylate or have
intolerance of imatinib mesylate

- Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)

- Subjects must have primary or acquired resistance to chemotherapy or have intolerance
of chemotherapy

- Performance status (general conditions) specified by the Eastern Cooperative Oncology
Group: 0-2

- Men and women, ages 20 - 75

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 3 months after
the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

- Subjects who are eligible and willing to undergo transplantation at pre-study

- Women who are pregnant or breastfeeding

- Uncontrolled or significant cardiovascular disease

- History of significant bleeding disorder unrelated to CML or ALL

- Adequate hepatic function

- Adequate renal function

- Medication that increase bleeding risk

- Medication that change heart rhythms

- Subjects who are compulsorily detained for legal reasons or 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: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

CA180-031

NCT ID:

NCT00337454

Start Date:

July 2005

Completion Date:

March 2007

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Imatinib resistant or intolerant CML
  • Treatment resistant or intolerant Ph+ALL
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

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