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

Who is this study for? Adult patients with Acute Myeloid Leukemia or Acute Promyelocytic Leukemia
What treatments are being studied? Arsenic Trioxide
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The investigators have formulated an oral preparation of arsenic trioxide (oral-ATO), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients \[8,9\]. Furthermore, in an effort to prevent relapse, the investigators have moved oral-ATO forward to the maintenance of CR1. This strategy results in favorable overall-survival (OS) and leukemia-free-survival (LFS) \[10\], implying that prolonged treatment with oral-ATO may prevent relapses. Current protocols have incorporated i.v.-ATO in the treatment of newly-diagnosed APL \[11-15\]. For regimens comprising oral-ATO, ATRA and chemotherapy, 5-year OS in excess of 90% is achieved \[11-15\]. The investigators have also published long-term data showing the use of oral-ATO is highly effective and safe in the relapsed and frontline settings \[16,17\]. In this study, the investigators evaluate the use of oral-ATO and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Newly diagnosed APL with t(15;17)(q24;q21) or acute myeloid leukaemia (AML) with variant RARA translocation according to the World Health Organization (WHO) Classification 2022

• Ability and willingness to comply with the study procedures and restrictions

• Voluntary written informed consent

Locations
Other Locations
Hong Kong Special Administrative Region
The University of Hong Kong
RECRUITING
Hong Kong
Singapore
National University Hospital Singapore
RECRUITING
Singapore
Contact Information
Primary
Harry Gill, MD
gillhsh@hku.hk
+852 22554542
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 100
Treatments
Experimental: Oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA)
Induction: Oral arsenic trioxide 10mg daily (0.16mg/kg/day in patients \< 18 years-old, all-trans retinoic acid (ATRA) \[45mg/m\^2 (25mg/m\^2 per day in patients \< 18 years-old) in 2 divided doses) and ascorbic acid 1g daily (15mg/kg/day in patients \< 18 years-old) for 42 days Consolidation: Oral arsenic trioxide daily, ATRA, and ascorbic acid daily for 14 days every 28 days for 2 cycles.~Maintenance: Oral arsenic trioxide, ATRA and ascorbic acid daily for 2 weeks every 8 weeks for a total of 2 years (i.e. for 12 cycles in total).
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov

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