Growth Factor Signature (GFS) Pilot Study (MK0000-098)(COMPLETED)
Condition: Blast Phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML); Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Blast Crisis; Philadelphia Chromosome
Intervention: Comparator: Biomarker evaluation
Intervention description: Patients on standard of care treatment will have blood drawn to evaluate biomarker changes in response to treatment with BCR-ABL inhibitors over a ~3.5 month period.
Part I will enroll patients who are beginning treatment with imatinib (recommended dose 400 mg every day [qd]), dasatinib (recommended dose 70 mg twice a day [bid]), or nilotinib (recommended dose 400 mg bid).
Part II will enroll patients who are changing from imatinib therapy to either dasatinib or nilotinib. A decision to initiate Part II will be made based on analysis of the results of Part I.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate a gene expression signature (Growth Factor Signature [GFS]) as a
      biomarker for response/resistance to BRC-ABL oncogene inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have a histologically or cytopathologically confirmed blast phase Ph+
             CML or Ph+ ALL.

          -  Participant is 18 years of age on the day of signing informed consent

          -  Participant must have performance status 0-3 on the Eastern Cooperative Oncology Group
             (ECOG) Performance Scale

          -  Participant has at least 30 percent blasts in peripheral blood; or at least 30 percent
             lymphoblasts in peripheral blood or bone marrow

               -  For Part II:

          -  Participant has progressed while taking imatinib or is unable to tolerate imatinib,
             being defined as discontinuing imatinib treatment as a result of nonhematologic toxic
             effects of any grade

          -  If female, participant is either post-menopausal, free from menses for >2 years,
             surgically sterilized or willing to use 2 adequate barrier methods of contraception to
             prevent pregnancy or agrees to abstain from heterosexual activity throughout the
             study, starting with Visit 1

          -  Female participants of childbearing potential must have a negative serum or urine
             pregnancy test (beta hCG) at screening

          -  If male, participant is surgically sterilized, agrees to use an adequate method of
             contraception, or agrees to abstain from heterosexual activity for the duration of the
             study

          -  Participant or the patrticipant's legal representative has voluntarily agreed to
             participate by giving written informed consent

          -  Participant must be available for periodic blood sampling, study related assessments,
             and management at the treating institution for the duration of the study

        Exclusion Criteria:

          -  Participant is currently participating in or has participated in a study with an
             investigational compound or device within 30 days or 5 half-lives, whichever is
             longer, of the start of treatment

          -  Participant has known human immunodeficiency virus (HIV) infection or HIV-related
             malignancy

          -  Participant is a female who is pregnant or breastfeeding, or is expecting to conceive
             within the projected duration of the study

          -  Participant has a known allergy or hypersensitivity to imatinib, dasatinib or
             nilotinib

          -  Participant has a history or current evidence of any condition, therapy, or laboratory
             abnormality that might confound the results of the study, interfere with the
             participant's participation for the full duration of the study, or is not in the best
             interest of the participant to participate

          -  Participant has known psychiatric or substance abuse disorders that would interfere
             with cooperation with the requirements of the trial

          -  There is any concern by the investigator regarding the safe participation of the
             participant in the study or for any other reason, the investigator considers the
             participant inappropriate for participation in the study