1336GCC: Open-Label, Single-Arm PK Study of IV Erwinaze (Asparaginase Erwinia Chrysanthemi) to Find the Dose With Acceptable Therapeutic and Safety Profile in Adults With Acute Myeloid Leukemia With or Without Isocitrate Dehydrogenase Mutations
Sponsor study identifier
interventional
5
1 country
1
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
September 2017
Actual (reported)Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6 doses MWF over a period of 2 weeks to 9 patients (as described below and in the following schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation studies including fibrinogen will be measured and reviewed before each asparaginase dose. Fibrinogen (\<100 mg/dL) can be replaced with cryoprecipitate before each dose at the discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase or direct bilirubin above normal range.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 17, 2014
Actual (reported)November 5, 2014
Actual (reported)December 2015
Actual (reported)September 2017
Actual (reported)To determine the dose of Erwinase that produces a plasma glutamine level ≤120 μmol/L with an acceptable safety profile.
The dose of Erwinase that produces a plasma glutamine level ≤120 µmol/L with an acceptable safety profile.
Day 3
Efficacy of Erwinase doses as measured by plasma glutamine level
The dose of Erwinase that produces a plasma glutamine level ≤120 µmol/L with an acceptable safety profile.
Day 5
Efficacy of Erwinase doses as measured by plasma glutamine level
The dose of Erwinase that produces a plasma glutamine level ≤120 µmol/L with an acceptable safety profile.
Day 8
Efficacy of Erwinase doses as measured by plasma glutamine level
The dose of Erwinase that produces a plasma glutamine level ≤120 µmol/L with an acceptable safety profile.
Day 10
Efficacy of Erwinase doses as measured by plasma glutamine level
The dose of Erwinase that produces a plasma glutamine level ≤120 µmol/L with an acceptable safety profile.
Day 12
Efficacy of Erwinase doses as measured by nadir serum asparaginase activity
Days 3, 5,8,10,12, & 42
Efficacy of Erwinase as measured by acute myeloid leukemia (AML) disease response
Days 15 and 29
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
30 days from last dose of drug or until death, whichever occurs first
Validity of serum and urine 2-hydroxyglutarate (2-HG) as a biomarker for AML with or without IDH mutation
Days 0, 8, & 42
Six doses of Erwinase given three times weekly (Monday-Wednesday-Friday) for two weeks. Possible dose levels used are 20.000 IU/m2/day, 25,000IU/m2/day, and 30,000IU/m2/day.
Six doses of Erwinase, given Monday-Wednesday-Friday for 2 weeks. Dosage levels to be used are: 20,000 IU/ m2 /day, 25,000 IU/ m2 /day, 30,000 IU/ m2 /day.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Ashkan Emadi, MD, PhD
University of Maryland
5 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2014
First Posted
November 5, 2014
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of Erwinase doses as measured by plasma glutamine level
The dose of Erwinase that produces a plasma glutamine level ≤120 µmol/L with an acceptable safety profile.
Day 42
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
September 2017
Actual (reported)Last Updated
March 12, 2018
Record last verified: 2018-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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