A Pilot Study of ODSH in Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A Pilot Study of ODSH in Acute Myeloid Leukemia

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantex Pharmaceuticals
• Collaborator: Translational Drug Development

Criteria

Inclusion Criteria:

• Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia and acute megakaryoblastic leukemia subtypes are excluded

• No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed

• Age: ≥18

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

• Cardiac ejection fraction ≥ 50% (echocardiography or Multi-Gated Acquisition Scan [MUGA])

• Adequate hepatic and renal function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin and creatinine < 2.5 x upper normal limit).

• Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

• Patients with acute promyelocytic leukemia

• Patients with acute megakaryoblastic leukemia

• Patients with Central Nervous System (CNS) leukemia

• Presence of uncontrolled bleeding

• Presence of significant active infection that is uncontrolled as judged by the investigator

• History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin

• Pre-existing liver disease

• Renal insufficiency, which, in the opinion of the investigator, might adversely affect schedule and dose of therapy with cytarabine as well as management of tumor lysis syndrome. Patients with creatinine levels ≥2 mg/dl are not eligible

• Use of recreational drugs or history of drug addiction, within the prior 6 months

• Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies

• Known history of positive test for Human Immunodeficiency Virus (HIV) antibodies

• Psychiatric or neurologic conditions that could compromise patient safety or compliance, or interfere with the ability to give proper informed consent

• History of other active malignant disease within 5 years, other than cured basal cell carcinoma of the skin, cured in situ carcinoma of the cervix, or localized prostate cancer that has received definitive therapy. Such prostate cancer patients who are receiving hormonal therapy are eligible

• Presence of disseminated intravascular coagulation, as confirmed by laboratory studies demonstrating evidence of both increased thrombin generation (decreased fibrinogen, prolonged Prothrombin Time [PT] and Partial Thromboplastin Time [aPTT]) as well as increased fibrinolysis (elevated D-dimer level)

• Patients receiving any form of anticoagulant therapy

• Presence of a known bleeding disorder or coagulation abnormality

• Treatment with any other investigational agent within 7 days prior to study entry. All prior toxicities should have resolved to no greater than Grade 1 (with the exception of alopecia)

• Pregnant or breast-feeding patients

• Patient with childbearing potential not using adequate contraception

• Any condition that requires maintenance of platelet counts at 50,000/μL or higher.