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Acute Myeloid LeukemiaPhase 2NCT02899286

Efficacy and Safety Study of Recombinant Human Arginase 1 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 2 study testing PEG-BCT-100 in people with Acute Myeloid Leukemia, run by Bio-Cancer Treatment International Limited at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute myeloid leukemia (AML) in terms of remission rate. 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?
PEG-BCT-100
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteHong Kong
Study dates
Sep 2016to Mar 2020
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

  • Adult patients ≥18 year-old at the time of informed consent
  • Documented relapsed or refractory AML after at least two standard chemotherapy regimen or in whom the treating physicians considered unfit for further chemotherapy treatment
  • The Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
  • Patients from whom valid consent is obtained

Who cannot join

  • Patients who have received any induction chemotherapy, investigational treatment and arginine depleting agent within 2 weeks prior to the start of the PEG-BCT-100 (not including hydroxyurea or thioguanine)
  • Any toxic effects (except hair loss) of the prior therapy have not been resolved to Grade 1 or less according to National Cancer Institute Common Terminology Criteria for Adverse Events
  • Total bilirubin > 1.5 x Upper Limit of Normal (ULN) not related to haemolysis or Gilbert's disease, and ratio of concentrations of aspartate transaminase and alanine transaminase (AST/ALT) > 5 x ULN
  • Creatinine > 2 x ULN or estimated glomerular filtration rate using Modification of Diet in Renal Disease formula < 60 ml/min/1.73 m2
  • Second active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
  • Uncontrolled concomitant illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
Show all 12Show fewer
  • History of HIV-1 seropositivity
  • Active infection not adequately responding to appropriate therapy
  • Patient is pregnant or lactating
  • Female with childbearing potential who is not willing to use contraceptive methods which, in the opinion of the investigator, are effective and adequate while on study treatment and for 6 months after the last dose of study treatment
  • Male with a female partner with childbearing potential who is not willing to use contraceptive methods which, in the opinion of the investigator, are effective and adequate while on study treatment and for 6 months after the last dose of study treatment
  • Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase II Open-label Study of the Efficacy and Safety of Recombinant Human Arginase 1 (PEG-BCT-100) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute myeloid leukemia (AML) in terms of remission rate.

Read the detailed description

This is a phase 2, non-randomised, open-label study that aims at evaluating the efficacy of single agent PEG-BCT-100 in adult patients with relapsed/refractory AML. Eligible patients will receive intravenous (IV) infusion of PEG-BCT-100 weekly until disease progression, unacceptable drug-related toxicity(ies), allogeneic haematopoietic stem cell transplantation or withdrawal of subject consent.

Pharmacokinetic (PK) of PEG-BCT-100 and pharmacodynamics (PD) activity of PEG-BCT-100 on arginine depletion will be evaluated throughout the study. Plasma arginine level, intracellular blast arginine level (IBAL) in peripheral blood (PB) and bone marrow (BM) will be measured at specific time points. PEG-BCT-100 will be given once weekly at 1600 Units/kg (2.7mg/kg) per dose for three weeks (Cycle 1). If the post-treatment IBAL-BM examined within 5 days prior to each cycle fails to drop at least 70% from baseline value and disease response fails to achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi), PEG-BCT-100 may be increased to 2500 U/kg (the maximum tolerated dose as reported previously) at investigator's discretion. Disease response will be assessed within 5 days prior to each cycle according to the International Working Group (IWG) AML Response Criteria.

Safety and toxicity will be assessed through physical examinations, vital signs, blood tests and urinalysis throughout the study. Adverse event (AE) and serious adverse events (SAE) will be reported according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.03 (CTCAE v4.03) until 28 days after the last dose of PEG-BCT-100.

Immunogenicity response including anti-drug antibody (ADA) level and neutralizing antibody level will be assessed weekly for the first 2 cycles of PEG-BCT-100, pre-dose of each cycle thereafter and End of Study (EoS). Specific response predictive biomarkers in circulating and BM blasts, and emerging genetic markers will also be explored in the study.

Being tested
PEG-BCT-100
Keywords
Acute myeloid leukemia, AML, pegylated recombinant human arginase, PEG-BCT-100
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.

  • PEG-BCT-100Biological

    PEGylated recombinant human arginase

Study groups in NCT02899286
Study groupRoleWhat they receive
PEG-BCT-100ExperimentalPEG-BCT-100 (PEGylated recombinant human arginase)
Receives: Biological: PEG-BCT-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission (CR) rate

    Measured: 3 years

Secondary outcomes (16)

  1. Overall response rate (ORR)

    proportion of patients achieving CR or CRi or partial remission (PR)

    Measured: 3 years

  2. Duration of remission

    Measured: 3 years

  3. Time to progression (TTP)

    Measured: 3 years

  4. Progression-free survival (PFS)

    Measured: 3 years

  5. Overall survival (OS)

    Measured: 3 years

  6. AE and SAE

    Incidence of AE and SAE by severity grading as assessed according to CTCAE v4.03

    Measured: 3 years

  7. PK - Area under the plasma concentration versus time curve (AUC)

    Measured: 2 years

  8. PK - Peak plasma concentration of PEG-BCT-100 after administration (Cmax)

    Measured: 2 years

  9. PK - Lowest concentration that PEG-BCT-100 reaches before the next dose is administered (Cmin)

    Measured: 2 years

  10. PK - clearance

    Measured: 2 years

  11. PK - volume of distribution

    Measured: 2 years

  12. PK - elimination half-life

    Measured: 2 years

  13. PD

    arginine depletion

    Measured: 2 years

  14. PK/PD relationship

    dose response

    Measured: 2 years

  15. Anti-drug antibody (ADA)

    amount of ADA in patient sample (ng/mL)

    Measured: 2 years

  16. neutralizing anti-drug antibody (nADA)

    amount of nADA in patient sample (ng/mL)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionSep 2019 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02899286
Sponsor's protocol ID
BCT-100-007
Status last verified
Jul 2017
First submitted
6 Sep 2016
Last updated
28 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-BCT-100 in people with Acute Myeloid Leukemia, run by Bio-Cancer Treatment International Limited at 1 site in Hong Kong.

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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. 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?

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?

Complete remission (CR) rate (time frame: 3 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 NCT02899286.

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 28 Jul 2017.

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