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Trial record 1 of 1 for:    NCT02056782
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A Pilot Study of ODSH in Acute Myeloid Leukemia (PGX-AML)

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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

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE February 6, 2014
Last Update Posted Date February 16, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02056782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of ODSH in Acute Myeloid Leukemia
Official Title  ICMJE 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
Brief Summary A Pilot Study of ODSH in Acute Myeloid Leukemia
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: PGX-ODSH-2013-AML-1
See Intervention Description
Intervention: Drug: PGX-ODSH-2013-AML-1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056782
Other Study ID Numbers  ICMJE PGX-ODSH-2013-AML-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cantex Pharmaceuticals
Study Sponsor  ICMJE Cantex Pharmaceuticals
Collaborators  ICMJE Translational Drug Development
Investigators  ICMJE
Study Director: Stephen Marcus, MD Cantex Pharmaceuticals
Principal Investigator: Paul Shami, MD University of Utah Huntsman Cancer Institute & DSMB
PRS Account Cantex Pharmaceuticals
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP