Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    20927132 [PUBMED-IDS]
Previous Study | Return to List | Next Study

A Pilot Study of ODSH in Acute Myeloid Leukemia (PGX-AML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056782
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : February 16, 2015
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
Cantex Pharmaceuticals

Brief Summary:
A Pilot Study of ODSH in Acute Myeloid Leukemia

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: PGX-ODSH-2013-AML-1 Phase 1

Detailed Description:

This is an open-label, multi-center, 10 patient pilot study with an anticipated 1 year enrollment period

Primary Objectives:

  1. To evaluate the safety and tolerability of ODSH in patients with Acute Myeloid Leukemia (AML) receiving cytarabine and idarubicin induction or cytarabine consolidation chemotherapy.
  2. To determine whether there is preliminary evidence of an effect of ODSH on time to transfusion-independent platelet recovery in Acute Myeloid Leukemia (AML) patients receiving cytarabine and idarubicin induction or cytarabine consolidation chemotherapy.

Secondary Objectives:

  1. To determine whether there is preliminary evidence of an effect of ODSH on remission rate following cytarabine and idarubicin induction in Acute Myeloid Leukemia (AML) patients.
  2. To determine whether there is preliminary evidence of an effect of ODSH on improving platelet nadir counts in Acute Myeloid Leukemia (AML) patients receiving cytarabine and idarubicin induction or cytarabine consolidation chemotherapy.
  3. To determine whether there is preliminary evidence of an effect of ODSH on decreasing the number of platelet transfusions in Acute Myeloid Leukemia (AML) patients receiving cytarabine and idarubicin induction or cytarabine consolidation chemotherapy.
  4. To determine whether there is preliminary evidence of an effect of ODSH on reducing overall side effects of chemotherapy in Acute Myeloid Leukemia (AML) patients receiving cytarabine and idarubicin induction or cytarabine consolidation chemotherapy.

Enrollment for newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia and acute megakaryoblastic leukemia subtypes are excluded.

All patients will receive standard induction chemotherapy with cytarabine 100 mg/m2/day by continuous intravenous infusion over 24 hours daily for 7 days (D 1-7) plus idarubicin 12 mg/m2/day by intravenous injection daily for 3 days (D 1-3). For consolidation, patients younger than 60 will receive cytarabine at a dose of 3 grams/m2 over 3 hours, every 12 hours on days 1, 3, and 5.

Induction cycle: ODSH 4 mg/kg IV bolus day 1, 30 minutes after completion of administration of the first dose of idarubicin, then ODSH 0.25 mg/kg/hour for 24 hours daily by continuous IV infusion days 1-7.

Consolidation cycle: ODSH 4 mg/kg IV bolus day 1 administered 30 minutes after completion of infusion of the first dose of cytarabine then ODSH 0.25 mg/kg/hour for 24 hours daily by continuous IV infusion days 1-5

7 days in induction cycle and 5 days in consolidation cycles


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2 O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia
Study Start Date : December 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015


Arm Intervention/treatment
Experimental: PGX-ODSH-2013-AML-1
See Intervention Description
Drug: PGX-ODSH-2013-AML-1

Eligible patients will receive idarubicin at 12 mg/m2 days 1-3 of induction plus a seven-day continuous infusion of cytarabine at 100 mg/m2/day days 1-7 of induction. For consolidation, patients younger than 60 will receive cytarabine at 3 grams/m2 over 3 hours every 12 hours days 1, 3, and 5 of the cycle. Patients over 60 will come off study following induction.

In induction, ODSH will be administered as a 4 mg/kg bolus 30 minutes after the first idarubicin dose followed immediately by a continuous intravenous ODSH infusion of 0.25 mg/kg/hour for 24 hours daily for seven consecutive days (days 1-7) for a total of 168 hours of continuous ODSH infusion.

In consolidation, ODSH will be administered as a 4 mg/kg bolus 30 minutes after completion of the first 3-hour infusion of cytarabine, followed immediately by a continuous ODSH intravenous infusion of 0.25 mg/kg/hour for 24 hours daily for five consecutive days (days 1-5) for a total of 120 hours of continuous ODSH infusion.





Primary Outcome Measures :
  1. To evaluate the safety and tolerability of ODSH in patients with Acute Myeloid Leukemia (AML) receiving cytarabine and idarubicin induction or cytarabine consolidation chemotherapy [ Time Frame: Outcome measured daily, for change, in the first 35 days ]
    The primary endpoint is the safety and tolerability of ODSH in patients with Acute Myeloid Leukemia (AML) receiving cytarabine and idarubicin induction and cytarabine consolidation chemotherapy. Safety events will be tabulated and reported by type of adverse event and grade. Primary endpoints will be evaluated using descriptive statistics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia and acute megakaryoblastic leukemia subtypes are excluded
  • No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed
  • Age: ≥18
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Cardiac ejection fraction ≥ 50% (echocardiography or Multi-Gated Acquisition Scan [MUGA])
  • Adequate hepatic and renal function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], 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 Central Nervous System (CNS) leukemia
  • Presence of uncontrolled bleeding
  • Presence of significant active infection that is uncontrolled as judged by the investigator
  • History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin
  • Pre-existing liver disease
  • Renal insufficiency, which, in the opinion of the investigator, might adversely affect schedule and dose of therapy with cytarabine as well as management of tumor lysis syndrome. Patients with creatinine levels ≥2 mg/dl are not 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 virus (HCV) antibodies
  • Known history of positive test for Human Immunodeficiency Virus (HIV) antibodies
  • Psychiatric or neurologic conditions that could compromise patient safety or compliance, or interfere with the ability to give proper informed consent
  • 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
  • Presence of disseminated intravascular coagulation, as confirmed by laboratory studies demonstrating evidence of both increased thrombin generation (decreased fibrinogen, prolonged Prothrombin Time [PT] and Partial Thromboplastin Time [aPTT]) as well as increased fibrinolysis (elevated D-dimer level)
  • Patients receiving any form of anticoagulant therapy
  • Presence of a known bleeding disorder or coagulation abnormality
  • Treatment with any other investigational agent within 7 days prior to study entry. All prior toxicities should have resolved to no greater than Grade 1 (with the exception of alopecia)
  • Pregnant or breast-feeding patients
  • Patient with childbearing potential not using adequate contraception
  • Any condition that requires maintenance of platelet counts at 50,000/μL or higher.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056782


Locations
Layout table for location information
United States, Georgia
Georgia Regents University Augusta - Div. of Hematology/Oncology - BMT
Agusta, Georgia, United States, 30912
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Utah
University of Utah Huntsman Cancer Institute - Div. of Hematology & Hematologic Malignncies
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Cantex Pharmaceuticals
Translational Drug Development
Investigators
Layout table for investigator information
Study Director: Stephen Marcus, MD Cantex Pharmaceuticals
Principal Investigator: Paul Shami, MD University of Utah Huntsman Cancer Institute & DSMB

Publications:
Greer JP, Baer MR, Kinney MC. Acute Myelogenous Leukemia in Adults. In Wintrobe's Clinical Hematology. Lee GR et al ed. Williams and Wilkins, Baltimore, 2098-2142, 2004.
Lambert MP, Sharma SS, Xiao L, Marcus S et al. 2-O, 3-O-Desulfated Heparin (ODSH) Mitigates Chemotherapy-Induced Thrombocytopenia (CIT) by Blocking the Negative Paracrine Effect of Platelet Factor 4 (PF4) On Megakaryopoiesis. Proceedings of the 54th Annual Meeting of the American Society of Hematology. Abstract 386, 2012.
Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26;404-413, 1934.

Layout table for additonal information
Responsible Party: Cantex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02056782     History of Changes
Other Study ID Numbers: PGX-ODSH-2013-AML-1
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2014
Keywords provided by Cantex Pharmaceuticals:
Acute Myeloid Leukemia
AML
ODSH
ODSH-AML
Cantex
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms