The Acute Promyelocytic Leukaemia Asian Consortium (APL-AC) Project

October 3, 2022 updated by: The University of Hong Kong
There is currently lack of collaborative data on the epidemiology, clinicopathologic features and treatment outcome of newly diagnosed and relapsed APL in Asia. In addition, there is lack of data comparing oral- As2O3-based regimens with other treatment approaches, including intravenous As2O3,in the frontline or relapsed setting. With the long-term data of oral-As2O3 based regimen for APL available from Hong Kong, retrospective and prospective comparison with other treatment approaches in other Asian countries will generate important information to pave the way for widespread application of oral-As2O3 outside Hong Kong.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Acute promyelocytic leukemia (APL) is characterized by t(15;17)(q24;21) and the fusion gene PML-RARA.1 In newly-diagnosed patients, optimal supportive care together with the use of all-trans retinoic acid (ATRA) and chemotherapy results in first complete remission (CR1) in excess of 90% with durable remissions in about 80% of patients.Arsenic trioxide (As2O3) given intravenously (i.v.-As2O3) is highly efficacious for APL in first relapse (R1), inducing second complete remission (CR2) in more than 90% of patients. We have formulated an oral preparation of As2O3 (oral-As2O3), and shown that it is efficacious for APL in R1, giving CR2 rates of more than 90% in both adults and children. For patients in CR2, a 2-year maintenance with oral-As2O3 results in durable remission and long-term survivals in more than 60% and 70% of patients respectively strongly suggesting that hematopoietic stem cell transplantation (HSCT) could be obviated in such patients. With these results, we implemented oral-As2O3 maintenance in CR1 in Hong Kong and demonstrated very favourable overall-survival (OS) and leukemia-free-survival (LFS). This implied that that prolonged oral-As2O3 treatment may prevent relapses.

Meanwhile, i.v.-As2O3 has also been tested in the frontline treatment of newly-diagnosed APL.These studies employed different strategies, recruiting a mixture of low-, intermediate- to high-risk patients and placing i.v.-As2O3 in induction and/or consolidation. During induction, i.v.-As2O3 was combined with ATRA, with additional gemtuzumab ozogamicin (an anti-CD33 immunoconjugate) or chemotherapy. During consolidation, i.v.-As2O3 was combined with conventional chemotherapy. Their results all indicated that frontline use of i.v.-As2O3 in induction and/or consolidation improved the outcome of newly-diagnosed APL patients. However, with quite diverse protocols and the enrollment in some studies of only patients with low to intermediate risks, and in other studies of patients with all risk categories; the optimal strategy of employing i.v.-As2O3 in newly-diagnosed APL remains to be defined. We have tested oral- As2O3 in combination with ATRA, ascorbic acid (AAA) with daunorubicin in both low-risk and high-risk APL with 3 year LFS and OS of both 100%.

With the impressive results of oral-As2O3-based regimen in newly diagnosed and relapsed APL, an important future perspective is the application of this relatively economical and convenient approach to the treatment of patients with APL in Asia and other developing countries around the world where the cost and availability of intravenous formulation of As2O3 is a concern. There is currently lack of collaborative data on the epidemiology, clinicopathologic features and treatment outcome of newly diagnosed and relapsed APL in Asia. In addition, there is lack of data comparing oral- As2O3-based regimens with other treatment approaches, including intravenous As2O3,in the frontline or relapsed setting. With the long-term data of oral-As2O3 based regimen for APL available from Hong Kong, retrospective and prospective comparison with other treatment approaches in other Asian countries will generate important information to pave the way for widespread application of oral-As2O3 outside Hong Kong.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Harinder Singh Harry Gill, MD
  • Phone Number: +852 22554542
  • Email: gillhsh@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Medicine, the University of Hong Kong, Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a retrospective-prospective cohort study for all patients diagnosed with acute promyelocytic leukaemia since 2010 in Hong Kong and participating countries in Asia.

Description

Inclusion criteria:

  • Patients aged 18 or above
  • Acute promyelocytic leukaemia with PML/RARA
  • Acute myeloid leukaemia with variant RARA translocation

Exclusion criteria:

-Acute myeloid leukaemia without PML/RARA or variant RARA translocation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivals
Time Frame: 60 months
The primary outcome measures in this study include the overall survival (OS) and the relapse-free survival (RFS). OS is defined as the time (in months) from diagnosis to death from any cause (event) or latest follow-up. RFS is defined as the time from first complete remission (CR)/complete remission with incomplete haematological recovery (CRi) to first hamatologic relapse or molecular relapse (R1) (event), death from any cause (event) or latest follow-up (censor). CR, CRi, treatment failure, haematologic relapse are defined according to the 2017 European LeukemiaNet (ELN) recommendations. A molecular relapse is defined as recurrence of measurable residual disease (MRD) by reverse-transcriptase polymerase chain reaction (RT-PCR) or real-time quantitative PCR (qRT PCR). A single MRD positivity must be confirmed by performing the molecular assay within 2 weeks.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2020

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APLAC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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