Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia

Acute Promyelocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03624270
• Other study ID #: APL001
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: The University of Hong Kong
• Contact: Harinder Singh Harry Gill, MBBS
• Phone: +852 22554542
• Email: gillhsh[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Drug:
• Oral 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.

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, the University of Hong Kong, Queen Mary Hospital	Hong Kong	N/A = Not Applicable

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival: Time (in months) from diagnosis to death or latest follow-up	Time (in months) from diagnosis to death (event) or latest follow-up (censor)	60 months
Primary	Leukemia-free survival: Time (in months) from first remission to relapse, death or latest follow-up	Time (in months) from first remission to relapse (event), death (event) or latest follow-up (censor)	60 months
Secondary	Treatment Toxicity Grade	Treatment toxicities by Eastern Cooperative Oncology (ECOG)-Common Toxicity Criteria (CTC)	60 months