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Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia

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ClinicalTrials.gov Identifier: NCT03624270
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Acute Promyelocytic Leukemia Drug: Oral Arsenic Trioxide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk-stratified Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: Oral arsenic trioxide

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)

Consolidation:

- Daunorubicin 50mg/m2 per day for 2 days + cytarabine 100mg/m2 per day for 5 days every 4 to 6 weeks for 2 cycles

Consolidation (if WBC at diagnosis < 10 x 10^9/L; or aged ≥ 65 years; or cardiac function impairment):

- 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.

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




Primary Outcome Measures :
  1. Overall survival: Time (in months) from diagnosis to death or latest follow-up [ Time Frame: 60 months ]
    Time (in months) from diagnosis to death (event) or latest follow-up (censor)

  2. Leukemia-free survival: Time (in months) from first remission to relapse, death or latest follow-up [ Time Frame: 60 months ]
    Time (in months) from first remission to relapse (event), death (event) or latest follow-up (censor)


Secondary Outcome Measures :
  1. Treatment Toxicity Grade [ Time Frame: 60 months ]
    Treatment toxicities by Eastern Cooperative Oncology (ECOG)-Common Toxicity Criteria (CTC)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624270


Contacts
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Contact: Harinder Singh Harry Gill, MBBS +852 22554542 gillhsh@hku.hk

Locations
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Hong Kong
Department of Medicine, the University of Hong Kong, Queen Mary Hospital Recruiting
Hong Kong, N/A = Not Applicable, Hong Kong
Contact: Harinder Singh Harry Gill    +852 22554542    gillhsh@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Harinder Singh Harry Gill, MBBS Department of Medicine, the University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03624270     History of Changes
Other Study ID Numbers: APL001
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan for IPD to be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
Acute promyelocytic leukaemia
Oral arsenic trioxide
Additional relevant MeSH terms:
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Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic Trioxide
Antineoplastic Agents