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A Randomized Two-Arm, Multicenter, Open-Label Phase II Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Myeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Thank you

Trial Information

A Randomized Two-Arm, Multicenter, Open-Label Phase II Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



- Subjects with Ph+ (or BCR/ABL+) accelerated phase chronic myeloid leukemia whose
disease has primary or acquired hematologic resistance to imatinib mesylate or who
are intolerant of imatinib mesylate

- Men and women, 18 years of age or older

- Adequate hepatic function

- Adequate renal function

- 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

- ECOG performance status score 0 - 2

Exclusion Criteria:

- Women who are pregnant or breastfeeding

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

- Uncontrolled or significant cardiovascular disease

- Medications that increase bleeding risk

- Medications that change heart rhythms

- Dementia 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

- Prior therapy with BMS-35425

- 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the Complete Hematological Response rate of 70 and 140 mg of BMS-354825 in patients who have primary or acquired resistance to imatinib

Outcome Time Frame:

81 months

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:

CA180-035

NCT ID:

NCT00123487

Start Date:

June 2005

Completion Date:

July 2013

Related Keywords:

  • Myeloid Leukemia, Chronic, Accelerated Phase
  • Leukemia, Lymphoblastic, Acute, Philadelphia-positive
  • Accelerated Phase Chronic Myeloid Leukemia
  • Lymphoid Blast Phase Chronic Myeloid Leukemia
  • Myeloid Blast Phase Chronic Myeloid Leukemia
  • Philadelphia Positive Acute Lymphoblastic Leukemia
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Accelerated Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome
  • Chronic Disease

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Washington University School of MedicineSaint Louis, Missouri  63110
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Emory University School of MedicineAtlanta, Georgia  30322
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Seattle Cancer Care AllianceSeattle, Washington  98109
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Northwestern UniversityChicago, Illinois  60611
Nebraska Methodist HospitalOmaha, Nebraska  68114
University of MarylandBaltimore, Maryland  21201
The University Of North Carolina At Chapel HillChapel Hill, North Carolina  27599-7235
University of KentuckyLexington, Kentucky  40536-0098
University of MiamiMiami, Florida  33136
New York Presbyterian HospitalNew York, New York  10021
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
The University of ChicagoChicago, Illinois  60637
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Sarah Cannon Research InstituteNashville, Tennessee  37203
Karmanos Cancer CenterDetroit, Michigan  48201
Loma Linda University Cancer CenterLoma Linda, California  92354
Devetten, MarcelOmaha, Nebraska  68198
Ucla Dept. Of MedicineLos Angeles, California  90095
Dana Faber Cancer InstituteBoston, Massachusetts  02115
Oregon Health & Sci UnivPortland, Oregon  97239