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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Pilot Study to Evaluate the Safety and Preliminary Evidence of a Therapeutic Effect of ODSH (2-0, 3-0, Desulfated Heparin) in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843634
• Other study ID #: IRB 63137
• Status: Completed
• Phase: Early Phase 1
• Start date: August 2013
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Chimerix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ODSH

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Chimerix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety by incidence of serious events		12 months
Primary	Efficacy by time to platelet recovery		12 months