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An Open-Label Phase 2 Trial of LY2181308 Sodium Administered in Combination With Idarubicin and Cytarabine to Patients With Refractory or Relapsed Acute Myeloid Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

An Open-Label Phase 2 Trial of LY2181308 Sodium Administered in Combination With Idarubicin and Cytarabine to Patients With Refractory or Relapsed Acute Myeloid Leukemia


Inclusion Criteria:



- Patients who have a diagnosis of acute myeloid leukemia that is relapsed or
refractory to a least 1 prior treatment for leukemia, or patients with chronic
myeloid leukemia (CML) who are in myeloid blast crisis which have failed at least 1
previous tyrosine kinase inhibitor (TK1). A baseline bone marrow assessment is
required less than or equal to 96 hours prior to the first dose of study drug.

- Must have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational
therapy for at least 21 days for myelosuppressive agents (such as cytarabine,
daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents
prior to receiving study drug, and recovered from the acute effects of therapy (such
as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and
alopecia. Hydroxyurea is permitted to control the peripheral blast cell count, but
must be stopped at least 24 hours before study drug administration. administration.

- Must have adequate organ function.

- Females must have a negative pregnancy test. Male and female patients must agree to
use a reliable method of birth control during and for 6 months following the last
dose of study drug.

- Patients must be at least 18 years old.

Exclusion Criteria:

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication within 14 or 21 days of the initial dose of
study drug for a non-myelosuppressive or myelosuppressive agent, respectively.

- Patients with acute promyelocytic leukemia (APML).

- Major surgery within 4 weeks of study enrollment.

- Patients with serious pre-existing medical conditions (at the discretion of the
investigator). Because of the known cardiac toxicity of anthra- cyclines, patients
with pre-existing ejection fraction (EF) less than or equal to 45% should not
participate in this study. No patient should exceed the maximum exposure of
anthracycline doses (for example, idarubicin greater than 120mg/m2).

- Patients with a second malignancy that could affect the interpretation of the
results.

- Patients with leukemic involvement of the CNS by spinal fluid cytology or imaging.

- Patients with known coagulopathy or bleeding disorder, other than leukemia related
thrombocytopenia. Patients with severe of life threatening bleeding refractory to
platelet transfusions are also excluded.

- Concomitant anticoagulant therapy (with the exception of heparinized saline to
maintain the patency of central venous catheters).

- Women who are pregnant or breast feeding.

- Patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or
cytarabine.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To understand the safety profile of LY2181308 sodium administered in combination with idarubicin and cytarabine through adverse events and serious adverse events

Outcome Time Frame:

during treatment and follow up

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT-5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

11631

NCT ID:

NCT00620321

Start Date:

March 2008

Completion Date:

January 2010

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Kalamazoo, Michigan  49048
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bedford, Texas  76022