A Study for Patients With Acute Leukemia



Status:Terminated
Conditions:Other Indications, Blood Cancer
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:June 2008
End Date:February 2011

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Phase 1 Study of LY2523355 in Patients With Acute Leukemia

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 patients with acute leukemia. Part A and Part B are dose
escalation of two schedules in patients with acute leukemia. Parts A and B will enroll
concurrently. Part C is a dose expansion for each schedule in patients with acute
myeloblastic leukemia (AML).


Inclusion Criteria:

Dose escalation period for both schedules:

- Patient must have a confirmed diagnosis of acute leukemia regardless of sub-type 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 AML, should not be a
candidate for standard therapy, and a clinical trial is a preferred treatment option
or 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 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

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)
We found this trial at
5
sites
618
mi
from
Nashville, TN
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1444
mi
from
Boston, MA
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610
mi
from
Chicago, IL
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569
mi
from
Houston, TX
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643
mi
from
Indianapolis, IN
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