A Study for Patients With Acute Leukemia
Condition: Acute Leukemia
MeSH terms: Leukemia; Acute Disease
Intervention: LY2523355
Intervention description: Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia,Blast Crisis

Summary:

      This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient
      dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355
      that can be safely administered to participants with acute leukemia. Part A and Part B are
      dose escalation of two schedules in participants with acute leukemia. Parts A and B will
      enroll concurrently. Part C is a dose expansion for each schedule in participants with acute
      myeloblastic leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

        Dose escalation period for both schedules:

          -  Participants must have a confirmed diagnosis of acute leukemia regardless of sub-type
             and for whom experimental Phase 1 therapy is appropriate.

          -  Are greater than or equal to 18 years of age.

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale.

          -  Females with childbearing potential must have had a negative urine or serum pregnancy
             test less than or equal to 7 days prior to the first dose of study drug.

        Dose confirmation period for both schedules:

          -  Participant must have a confirmed diagnosis of untreated acute myeloblastic leukemia
             (AML), should not be a candidate for standard therapy, and a clinical trial is a
             preferred treatment option or have acute AML that is relapsed or refractory to no more
             than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not
             considered a prior regimen.

          -  Are greater than or equal to 60 years of age.

          -  Have a performance status of 0 or 1 on the ECOG scale.

          -  Females with childbearing potential must have had a negative urine or serum pregnancy
             test less than or equal to 7 days prior to the first dose of study drug.

        Exclusion Criteria:

          -  Have received treatment within 28 days of the initial dose of study drug with a drug
             that has not received regulatory approval for any indication.

          -  Participants with known central nervous system (CNS) leukemia by spinal fluid cytology
             or imaging. A lumbar puncture is not required unless CNS involvement is clinically
             suspected. Participants with signs or symptoms of leukemic meningitis or a history of
             leukemic meningitis must have a negative lumbar puncture within 2 weeks of study
             enrollment.

          -  Have other active malignancy (with the exception of basal and squamous cell skin
             cancer) at time of study entry.

          -  Have had an autologous or allogenic bone marrow transplant within 3 months. All organ
             toxicity must be resolved.

          -  Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant.

          -  Have uncontrolled systemic infection.

          -  Females who are pregnant or lactating.

          -  Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required).