Clinical trial NCT03624270: Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia
Official title: Risk-stratified Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Promyelocytic Leukemia
Keywords: Acute promyelocytic leukaemia
Oral arsenic trioxide
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival: Time (in months) from diagnosis to death or latest follow-up
timeFrame: 60 months
measure: Leukemia-free survival: Time (in months) from first remission to relapse, death or latest follow-up
timeFrame: 60 months
Secondary outcomes:
measure: Treatment Toxicity Grade
timeFrame: 60 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, the University of Hong Kong, Queen Mary Hospital
state: N/A = Not Applicable
Study officials:
affiliation: Department of Medicine, the University of Hong Kong
name: Harinder Singh Harry Gill, MBBS
role: PRINCIPAL_INVESTIGATOR
References: