Acute Myeloid LeukemiaPhase 2NCT01910012
PH 2 ADI-PEG 20 Acute Myeloid Leukemia
A Phase 2 study testing ADI-PEG 20 in people with Acute Myeloid Leukemia, run by Polaris Group at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- ADI-PEG 20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 6 Jan 2015to 5 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or cell surface marker criteria.
- Patients with AML must have either:
- 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.
- 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).
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Taiwan5 sites
Chang Gung Medical Foundation-Kaohsiung
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
CMUH
Taichung
NCKUH
Tainan
CGMH-LK
Taoyuan
About this study
Official title: Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia
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
- Being tested
- ADI-PEG 20
- Keywords
- Argininosuccinate Synthetase, Arginine, Arginine deiminase, Failed prior systemic therapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-PEG 20Drug
Also called arginine deiminase formulated with polyethylene glycol
| Study group | Role | What they receive |
|---|---|---|
| ADI-PEG 20 | Experimental | arginine deiminase formulated with polyethlene glycol Receives: Drug: ADI-PEG 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 2 years estimated
Secondary outcomes (1)
Safety and tolerability
- 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
Measured: 2 years estimated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study start6 Jan 2015
- Primary completion12 Sep 2016
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910012
- Sponsor's protocol ID
- POLARIS2012-001
- Status last verified
- Sep 2020
- First submitted
- 10 Jul 2013
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28900115
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01910012
- Acronym / sponsor ID
- POLARIS2012-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Argininosuccinate Synthetase, Arginine, Arginine deiminase, Failed prior systemic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADI-PEG 20 | Experimental | Drug: ADI-PEG 20arginine deiminase formulated with polyethlene glycol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or cell surface marker criteria.
- Patients with AML must have either:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-PEG 20Also: arginine deiminase formulated with polyethylene glycol | Drug | ADI-PEG 20 |
Primary outcome
Response Rate
Time frame: 2 years estimated
1 secondary outcome
Safety and tolerability
Time frame: 2 years estimated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 28900115Tsai 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADI-PEG 20 in people with Acute Myeloid Leukemia, run by Polaris Group at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 2 years estimated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.