Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

Chimerix

Status and phase

Completed

Early Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: ODSH

Study type

Interventional

Funder types

Industry

Identifiers

NCT01843634

IRB 63137

Details and patient eligibility

About

This is an open-label pilot study evaluating the safety and preliminary evidence of a therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard induction and consolidation therapy for acute myeloid leukemia.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia is excluded.
No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed.
No prior chemotherapy or lenalinomide for treatment of myelodysplastic syndrome.
Age: 18-70.
ECOG Performance status 0-2
Cardiac ejection fraction ≥ 50% (echocardiography or MUGA [multigated acquisition])
Adequate hepatic and renal function (AST [aminotransferase], ALT [alanine aminotransferase], 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 CNS (central nervous system) leukemia
Presence of significant active infection or uncontrolled bleeding
Any coexisting major illness or organ failure which contraindicates the dose-intensive chemotherapy regimen prescribed by this protocol
Pre-existing liver disease that might impair ODSH clearance
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
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 antibodies
Known history of positive test for HIV (Human immunodeficiency virus) antibodies
Psychiatric or neurologic conditions that could impair ability to give proper informed consent
Presence of symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia
Presence of uncontrolled thrombotic or hemorrhagic disorder
A medical condition that requires the need to be on chronic anticoagulation
Presence of any other serious uncontrolled medical disorder
Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry
Pregnant or breast-feeding patients
Patient with childbearing potential not using adequate contraception
Hemorrhage risk that requires maintenance of platelet counts at 50,000/uL or higher.
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results