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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADI-PEG 20 | Experimental | arginine deiminase formulated with polyethlene glycol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADI-PEG 20 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 2 years estimated |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability |
| 2 years estimated |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson | Houston | Texas | 77030 | United States | ||
| Chang Gung Medical Foundation-Kaohsiung |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28900115 | Derived | 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. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C512527 | ADI PEG20 |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Kaohsiung City |
| Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| CMUH | Taichung | Taiwan |
| NCKUH | Tainan | Taiwan |
| CGMH-LK | Taoyuan | Taiwan |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |