Acute Myeloid LeukemiaPhase 1NCT02875093
Ph 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With AML
A Phase 1 study testing ADI-PEG 20 and Cytarabine in people with Acute Myeloid Leukemia, run by Polaris Group at 3 sites in Taiwan.
Trial summary
Assessment of safety and tolerability of drug combination and determine time on treatment, Overall survival (OS) and response rate with patient disease burden, and type of disease Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- ADI-PEG 20 and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesTaiwan
- Study dates
- 20 Jan 2017to 10 Jul 2019
- Phase
- Phase 1
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AML diagnosed by morphologic (with >20% blasts in blood or bone marrow) and histochemical and/or cell surface marker criteria.
- Patients with AML must fall into one of the following:
- Patients with AML (i.e., > 20% bone marrow blasts) who are deemed unfit* for intensive chemotherapy with refractory or relapsed disease. The patients must have been refractory to at least one cycle of cytarabine containing regimens or at least two cycles of azacitidine or similar hypomethylating agents.
- Patients with untreated AML (i.e., > 20% bone marrow blasts) with intermediate risk karyotype (MRC risk group) who are deemed unfit for intensive chemotherapy.
- Patients with untreated AML with adverse risk karyotype (MRC risk group) who are deemed unfit for intensive chemotherapy and who are intolerant of azacitidine (or other hypomethylating agents) or who are unable to access azacitidine or other hypomethylating agents.
- Patients unfit for conventional intensive chemotherapy are defined as having at least one of the following based on the conceptual criteria of Ferrara (2013):
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- Advanced age (over 75 years).
- Cardiac impairment with ejection fraction ≤ 50% or heart failure (NYHA class 2) or ischemic heart disease with stable angina.
- Pulmonary impairment: chronic obstructive pulmonary disease (COPD) stage 1-2 (forced expiratory volume in one second [FEV1] > 49%) or other comparable respiratory disease with forced vital capacity (FVC) > 50%.
- Hepatic comorbidity with Child-Pugh grade A cirrhosis
- Chronic kidney disease stage 3 but with creatinine clearance > 30 mls/min
- Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
- Age > 17 years.
- ECOG performance status of 0-2.
- Bone marrow aspirate and/or biopsy for testing for ASS1-deficiency. This must be a fresh sample obtained after any prior chemotherapy and before enrollment in this study. ASS1-deficiency is not required for study entry, but the fresh bone marrow sample must be processed either before or within 1 week of first study dose (see Section 10 for more details).
Who cannot join
- A subject will not be eligible for study participation if he/she meets any of the exclusion criteria:
- Patients with uncontrolled 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), unstable angina, ventricular cardiac arrhythmia (other than ventricular ectopy), severe pulmonary comorbidity: COPD grade 3-4 (FEV1 <50%) or other comparable documented pulmonary disease with FVC <50%, or dyspnea at rest or requiring oxygen at home, cognitive impairment: current mental illness requiring psychiatric hospitalization, institutionalization or intensive outpatient management, or uncontrolled current cognitive status (as confirmed by the specialist; dependence on a caregiver is permitted as long as this is well controlled), severe hepatic comorbidity: liver Child-Pugh grade B-C cirrhosis or acute viral hepatitis, social situations that would limit compliance with study requirements or DIC causing coagulopathy not correctable with factor replacement.
- Subjects who have had any anti-leukemia 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.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
National Cheng Kung University Hospital
Tainan, 704
Chang Gung Memorial Hospital - Linkou
Taoyuan, 33305
About this study
Official title: Phase 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia
Assessment of safety and tolerability of drug combination and determine time on treatment, Overall survival (OS) and response rate with patient disease burden, and type of disease
- Conditions
- Acute Myeloid Leukemia
- Being tested
- ADI-PEG 20, Cytarabine
- 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
Investigational Medicine
CytarabineDrug
low-dose cytarabine 20 mg BID twice daily for 10 days, every 28 days
| Study group | Role | What they receive |
|---|---|---|
| ADI-PEG 20 Plus Low Dose Cytarabine | Other | This is a phase 1, open label trial of ADI-PEG 20 (18 and 36 mg/m2) weekly in combination with low-dose cytarabine (20 mg BID [twice daily] for 10 days, every 28 days) Receives: Drug: ADI-PEG 20; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: through study completion; anticipated to be 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start20 Jan 2017
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Why it stopped: Study Termination
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT02875093
- Sponsor's protocol ID
- POLARIS2016-001
- Status last verified
- May 2018
- First submitted
- 9 Aug 2016
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tsai HJ, Hsiao HH, Hsu YT, Liu YC, Kao HW, Liu TC, Cho SF, Feng X, Johnston A, Bomalaski JS, Kuo MC, Chen TY. Phase I study of ADI-PEG20 plus low-dose cytarabine for the treatment of acute myeloid leukemia. Cancer Med. 2021 May;10(9):2946-2955. doi: 10.1002/cam4.3871. Epub 2021 Mar 30.
PubMed 33787078
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02875093
- Acronym / sponsor ID
- POLARIS2016-001
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Termination
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 23 Aug 2016 (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.
Assessment of safety and tolerability of drug combination and determine time on treatment, Overall survival (OS) and response rate with patient disease burden, and type of disease
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 Plus Low Dose Cytarabine | Other | Drug: ADI-PEG 20, Drug: CytarabineThis is a phase 1, open label trial of ADI-PEG 20 (18 and 36 mg/m2) weekly in combination with low-dose cytarabine (20 mg BID [twice daily] for 10 days, every 28 days) |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- AML diagnosed by morphologic (with >20% blasts in blood or bone marrow) and histochemical and/or cell surface marker criteria.
- Patients with AML must fall into one of the following:
- Age > 17 years.
- ECOG performance status of 0-2.
- Bone marrow aspirate and/or biopsy for testing for ASS1-deficiency. This must be a fresh sample obtained after any prior chemotherapy and before enrollment in this study. ASS1-deficiency is not required for study entry, but the fresh bone marrow sample must be processed either before or within 1 week of first study dose (see Section 10 for more details).
Key exclusion criteria (6 listed)
- A subject will not be eligible for study participation if he/she meets any of the exclusion criteria:
- Patients with uncontrolled 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), unstable angina, ventricular cardiac arrhythmia (other than ventricular ectopy), severe pulmonary comorbidity: COPD grade 3-4 (FEV1 <50%) or other comparable documented pulmonary disease with FVC <50%, or dyspnea at rest or requiring oxygen at home, cognitive impairment: current mental illness requiring psychiatric hospitalization, institutionalization or intensive outpatient management, or uncontrolled current cognitive status (as confirmed by the specialist; dependence on a caregiver is permitted as long as this is well controlled), severe hepatic comorbidity: liver Child-Pugh grade B-C cirrhosis or acute viral hepatitis, social situations that would limit compliance with study requirements or DIC causing coagulopathy not correctable with factor replacement.
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 20Investigational Medicine | Drug | ADI-PEG 20 Plus Low Dose Cytarabine |
| Cytarabinelow-dose cytarabine 20 mg BID twice daily for 10 days, every 28 days | Drug | ADI-PEG 20 Plus Low Dose Cytarabine |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: through study completion; anticipated to be 2 years
Results and safety
The study was stopped early (reason given: Study Termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 33787078Tsai HJ, Hsiao HH, Hsu YT, Liu YC, Kao HW, Liu TC, Cho SF, Feng X, Johnston A, Bomalaski JS, Kuo MC, Chen TY. Phase I study of ADI-PEG20 plus low-dose cytarabine for the treatment of acute myeloid leukemia. Cancer Med. 2021 May;10(9):2946-2955. doi: 10.1002/cam4.3871. Epub 2021 Mar 30.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADI-PEG 20 and Cytarabine in people with Acute Myeloid Leukemia, run by Polaris Group at 3 sites in Taiwan.
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 15 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: stopped early, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Study Termination). Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: through study completion; anticipated to be 2 years). 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 NCT02875093, 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 5 Mar 2020.