Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia

Risk-stratified Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03624270

Enrollment

Registered

2018-08-10

Start date

2018-08-15

Completion date

2023-12-31

Last updated

2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Promyelocytic Leukemia

Keywords

Acute promyelocytic leukaemia, Oral arsenic trioxide

Brief summary

Acute promyelocytic leukemia (APL) is characterized by t(15;17)(q24;21) and the fusion gene PML-RARA. We have formulated an oral preparation of As2O3 (oral-As2O3), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients. Furthermore, in an effort to prevent relapse, we have moved oral-As2O3 forward to the maintenance of CR1. This strategy results in favorable overall-survival (OS) and leukemia-free-survival (LFS), implying that prolonged treatment with oral-As2O3 may prevent relapses. Current protocols have incorporated i.v.-As2O3 in the treatment of newly-diagnosed APL. In regimens comprising i.v.-As2O3, ATRA and chemotherapy, 5-year overall survivals in excess of 90% is achieved. In this study, we evaluate the use of oral-As2O3 and ATRA based induction regimens in newly diagnosed patients with APL. In this study, we evaluate the efficacy and tolerability of frontline oral arsenic trioxide-based regimen in newly diagnosed patients with acute promyelocytic leukaemia

Interventions

DRUGOral arsenic Trioxide, ATRA and ascorbic acid

Oral arsenic trioxide-based frontline induction, consolidation and maintenance will be provided to patients with newly diagnosed acute promyelocytic leukemia.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Newly diagnosed patients with acute promyelocytic leukaemia (APL) with t(15;17) (q24;q21)according to the World Health Organization (WHO) Classification 2016 * Patients aged ≥18 years * Able and willing to comply with the study procedures and restrictions * Having given voluntary written informed consent

Exclusion criteria

* ECOG performance status above 2 * Decompensated heart failure with left-ventricular ejection fraction of less than 40% and global hypokinesia on echocardiogram. * Prolonged corrected QT interval (QTc) \> 500ms, in the absence of electrolyte disturbances and medications known to prolong QTc * Significant liver function derangement (Bilirubin \> 3 times upper limit normal and/or ALT \> 5 times upper limit of normal) * Acute myeloid leukaemia with variant RARA translocation

Design outcomes

Primary

Measure	Time frame	Description
Overall survival: Time (in months) from diagnosis to death or latest follow-up	60 months	Time (in months) from diagnosis to death (event) or latest follow-up (censor)
Leukemia-free survival: Time (in months) from first remission to relapse, death or latest follow-up	60 months	Time (in months) from first remission to relapse (event), death (event) or latest follow-up (censor)

Secondary

Measure	Time frame	Description
Treatment Toxicity Grade	60 months	Treatment toxicities by Eastern Cooperative Oncology (ECOG)-Common Toxicity Criteria (CTC)

Countries

Hong Kong

Contacts

Primary ContactHarinder Singh Harry Gill, MBBS

gillhsh@hku.hk+852 22554542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026