Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia

NCT ID: NCT03624270

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2023-12-31

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

Conditions

Acute Promyelocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Frontline oral arsenic trioxide, ATRA and ascorbic acid (AAA)

Induction:

• Oral arsenic trioxide 10mg daily, all-trans retinoic acid (ATRA) (45mg/m2 per day in divided doses) and Ascorbic acid 1g daily for 42 days
• Daunorubicin at 50mg/m2 daily for 3 days (omitted if WBC at diagnosis < 10 x 10^9/L; or age ≥ 65 years; or cardiac function impairment)
• Hydroxyurea 2-4g per day if WBC > 5 x 10^9/L during the first 7 days of induction.

Consolidation (for all patients):

• Oral arsenic trioxide 10mg daily, all-trans retinoic acid (ATRA) (45mg/m2 per day in divided doses) and ascorbic acid 1g daily for 14 days every 28 days for 2 cycles

Maintenance (for all patients):

• Oral Arsenic trioxide 10mg daily, ATRA (45mg/m2 per day in divided doses) and ascorbic acid 1g daily for 2 weeks every 2 months for 24 months.

Group Type: EXPERIMENTAL

Oral arsenic Trioxide, ATRA and ascorbic acid

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harinder Singh Harry Gill, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, the University of Hong Kong

Locations

Department of Medicine, the University of Hong Kong, Queen Mary Hospital

Hong Kong, N/A = Not Applicable, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Harinder Singh Harry Gill, MBBS

Role: CONTACT

gillhsh@hku.hk

+852 22554542

Facility Contacts

Harinder Singh Harry Gill

Role: primary

gillhsh@hku.hk

+852 22554542

Other Identifiers

APL001

Identifier Type: -

Identifier Source: org_study_id