PH 2 ADI-PEG 20 Acute Myeloid Leukemia

NCT01910012 | Completed Phase 2

• 1 other identifier: POLARIS2012-001
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 6

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.

Conditions

Acute Myeloid Leukemia

Keywords

Argininosuccinate Synthetase; Arginine; Arginine deiminase; Failed prior systemic therapy

Outcome Measures

Primary Outcomes (1)

• Response Rate

  2 years estimated

Secondary Outcomes (1)

• Safety and tolerability

  2 years estimated

Study Arms (1)

ADI-PEG 20

EXPERIMENTAL

arginine deiminase formulated with polyethlene glycol

Drug: ADI-PEG 20

Interventions

ADI-PEG 20 DRUG

Also known as: arginine deiminase formulated with polyethylene glycol

ADI-PEG 20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or cell surface marker criteria.
• 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
• Age ≥ 18 years.
• ECOG performance status of 0-2.
• 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.

You may not qualify if:

• 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.
• Pregnancy or lactation.
• Expected non-compliance.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Polaris Group: lead

Study Sites (6)

MD Anderson

Houston, Texas, 77030, United States

Location

Chang Gung Medical Foundation-Kaohsiung

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

CMUH

Taichung, Taiwan

Location

NCKUH

Tainan, Taiwan

Location

CGMH-LK

Taoyuan District, Taiwan

Location

Related Publications (1)

• Tsai HJ, Jiang SS, Hung WC, Borthakur G, Lin SF, Pemmaraju N, Jabbour E, Bomalaski JS, Chen YP, Hsiao HH, Wang MC, Kuo CY, Chang H, Yeh SP, Cortes J, Chen LT, Chen TY. A Phase II Study of Arginine Deiminase (ADI-PEG20) in Relapsed/Refractory or Poor-Risk Acute Myeloid Leukemia Patients. Sci Rep. 2017 Sep 12;7(1):11253. doi: 10.1038/s41598-017-10542-4.

  PMID: 28900115 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

ADI PEG20; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 29, 2013
• Study Start: January 6, 2015
• Primary Completion: September 12, 2016
• Study Completion: May 5, 2017
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

US (1); TW (5)