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

NCT01843634 | Completed Early Phase 1 DMC

• 1 other identifier: IRB 63137
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Safety by incidence of serious events

  12 months

• Efficacy by time to platelet recovery

  12 months

Study Arms (1)

ODSH

EXPERIMENTAL

Drug: ODSH

Interventions

ODSH DRUG

ODSH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Paul J Shami, M.D.

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 10, 2021

Record last verified: 2015-08

Locations

US (1)