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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


Phase 0
18 Years
70 Years
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety by incidence of serious events

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Paul J Shami, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

IRB 63137

NCT ID:

NCT01843634

Start Date:

August 2013

Completion Date:

April 2016

Related Keywords:

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

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112