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

Chimerix1 site in 1 country10 target enrollmentAugust 2013

ConditionsAcute Myeloid Leukemia

InterventionsODSH

DrugsODSH

Overview

Phase: Early Phase 1
Intervention: ODSH
Conditions: Acute Myeloid Leukemia
Sponsor: Chimerix
Enrollment: 10
Locations: 1
Primary Endpoint: Safety by incidence of serious events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

April 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chimerix

Responsible Party

Sponsor

Eligibility Criteria

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.
•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