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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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


Primary Outcome

Survivals


Condition

Acute Promyelocytic Leukemia



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1000

Start Date

February 2, 2020

Completion Date

June 2025

Primary Completion Date

January 2025

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Harinder Gill, MD, +852 22554542, [email protected]

Location Countries

Hong Kong

Location Countries

Hong Kong

Administrative Informations


NCT ID

NCT04251754

Organization ID

APLAC001


Responsible Party

Sponsor

Study Sponsor

The University of Hong Kong


Study Sponsor

Harinder Gill, MD, Principal Investigator, The University of Hong Kong


Verification Date

February 2020