NCT02899286

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

September 6, 2016

Last Update Submit

July 27, 2017

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaAMLpegylated recombinant human arginasePEG-BCT-100

Outcome Measures

Primary Outcomes (1)

  • Complete remission (CR) rate

    3 years

Secondary Outcomes (16)

  • Overall response rate (ORR)

    3 years

  • Duration of remission

    3 years

  • Time to progression (TTP)

    3 years

  • Progression-free survival (PFS)

    3 years

  • Overall survival (OS)

    3 years

  • +11 more secondary outcomes

Study Arms (1)

PEG-BCT-100

EXPERIMENTAL

PEG-BCT-100 (PEGylated recombinant human arginase)

Biological: PEG-BCT-100

Interventions

PEG-BCT-100BIOLOGICAL

PEGylated recombinant human arginase

PEG-BCT-100

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

BCT-100

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Anskar Leung

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

September 6, 2016

First Posted

September 14, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2019

Study Completion

March 1, 2020

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

HK(1)