Dasatinib (BMS-354825) in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00101595
First received: January 12, 2005
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.


Condition Intervention Phase
Chronic Myeloid Leukemia
Leukemia, Lymphoblastic, Acute, Philadelphia-positive
Drug: Dasatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Major and overall hematologic response rates [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Durability of hematologic response and time to hematologic response (major and overall) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Assess cytogenetic and molecular responses [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Measure minor hematologic response rate in the imatinib resistant group [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Explore the role of BCR-ABL mRNA expression and point mutations in the BCR-ABL gene [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Measure the heath-related QOL using FACT-G [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To assess safety and tolerability of dasatinib [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Population PK [ Time Frame: first month ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure
Other Names:
  • BMS-354825
  • Sprycel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101595

  Show 60 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00101595     History of Changes
Obsolete Identifiers: NCT00110097
Other Study ID Numbers: CA180-015
Study First Received: January 12, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Lymphoid blast phase chronic myeloid leukemia
Philadelphia chromosome positive acute lymphoblastic leukemia

Additional relevant MeSH terms:
Blast Crisis
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014