Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia in Adults - a Multicentre Phase 2 Study

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    100
  • sponsor
    The University of Hong Kong
Updated on 21 October 2022
remission
hydroxyurea
daunorubicin

Summary

The investigators 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 [8,9]. Furthermore, in an effort to prevent relapse, the investigators have moved oral-As2O3 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-As2O3 may prevent relapses.

Current protocols have incorporated i.v.-As2O3 in the treatment of newly-diagnosed APL [11-15]. For regimens comprising As2O3, 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-As2O3 is highly effective and safe in the relapsed and frontline settings [16,17].

In this study, the investigators evaluate the use of oral-As2O3 and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study.

Description

After initial eligibility screening, patients will be recruited to oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA) based-induction for 42 days. Daunorubicin (50mg/m^2/day for 3 days) will only be used during induction in patients <65 with presenting white blood cell count (WBC) ≥ 10 x 10^9/L. In patients not receiving daunorubicin, hydroxyurea (2-4g/day) if WBC ≥ 5 x 10^9/L within the first 14 days of induction. Molecular monitoring monitoring with RQ-PCR or ddPCR for PML-RARA will be performed weekly during induction. A reassessment bone marrow aspirate will be performed on day 28 of induction for assessment of morphologic remission.

Four weeks after the completion of induction phase, all patients, regardless of initial WBC, will receive two cycles of chemotherapy-free AAA consolidation (14 days every 28 days).

Four weeks after completion of consolidation, all patients will receive 12 cycles of chemotherapy-free AAA maintenance (14 days every 8 week).

Molecular monitoring monitoring with RQ-PCR or ddPCR for PML-RARA will be performed during every 4 weeks during consolidation, every 8 weeks during maintenance, and every 3 months for 24 months after completion of maintenance.

Details
Condition Acute Promyelocytic Leukemia
Treatment Oral Arsenic Trioxide Formulation
Clinical Study IdentifierNCT04687176
SponsorThe University of Hong Kong
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 2016
Age ≥18 years
Ability and willingness to comply with the study procedures and restrictions
Voluntary written informed consent

Exclusion Criteria

ECOG performance score >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)
Glomerular filtration rate (GRF) by Cockcroft-Gault formula or eGFR (MDRD) of less than 30mL/min
Female subject who is lactating or has positive pregnancy test result prior to the first dose of study drug
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