PH 2 ADI-PEG 20 Acute Myeloid Leukemia

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. Identifier: NCT01910012
Recruitment Status : Active, not recruiting
First Posted : July 29, 2013
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Polaris Group

Brief Summary:
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.

Condition or disease Intervention/treatment Phase
AML Subjects Who Have Failed Prior Systemic Therapy Drug: ADI-PEG 20 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia
Study Start Date : June 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: ADI-PEG 20
arginine deiminase formulated with polyethlene glycol
Drug: ADI-PEG 20
Other Name: arginine deiminase formulated with polyethylene glycol

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 2 years estimated ]

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 2 years estimated ]
    • Time on treatment
    • Overall survival
    • Evaluate the response rate and correlate with patient disease burden, and type of disease.
    • Determine the pharmacodynamics of ADI-PEG 20
    • Determine the immunogenicity of ADI-PEG 20

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or cell surface marker criteria.
  2. Patients with AML must have either:

    (a) relapsed or refractory leukemia after receiving at least one prior conventional induction therapy. Those in early first relapse must not have a matched donor and/or they must not be a candidate for allogeneic stem cell transplantation (usually this would mean the patient is too ill, obese, has a co-morbid condition or is over the age of 55 years) or (b) poor-risk AML as defined below: (i) Treatment related AML, except if it is associated with favorable cytogenetics (e.g., inversion 16, t(16;16), t(8;21), t(15;17), and not a candidate for stem cell transplantation, or (ii) AML with an antecedent hematologic disease (e.g., MDS, myelofibrosis, polycythemia vera, etc.), and not a candidate for stem cell transplantation.

    (iii) De novo AML > 70 years of age. (iv) AML with unfavorable cytogenetics regardless of age (>18 years), if patients are not candidates for allogeneic transplantation. Unfavorable cytogenetics are the following: complex (>3 abnormalities), -7, -5, 7q-, 5q-, abnormalities of 11q23 excluding t(9;11), t(9;22), inversion 3, t(3;3), t(6;9).

    (c) Patients older than 60 years of age who had AML (i.e., > 20% bone marrow blasts) and no prior therapy for AML

  3. Age ≥ 18 years.
  4. ECOG performance status of 0-2.
  5. Post-menarche female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study.

Exclusion Criteria:

  1. Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study; patients on prophylactic antibiotics or antivirals are acceptable.
  2. Pregnancy or lactation.
  3. Expected non-compliance.
  4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, psychiatric illness, social situations that would limit compliance with study requirements or DIC.
  5. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both.
  6. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current diagnosis.

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 identifier (NCT number): NCT01910012

United States, Texas
MD Anderson
Houston, Texas, United States, 77030
Chang Gung Medical Foundation-Kaohsiung
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung, Taiwan
Tainan City, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Polaris Group

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Polaris Group Identifier: NCT01910012     History of Changes
Other Study ID Numbers: POLARIS2012-001
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2016

Keywords provided by Polaris Group:
Argininosuccinate Synthetase
Arginine deiminase

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type