Oral Arsenic Trioxide for NPM1-mutated AML
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|ClinicalTrials.gov Identifier: NCT04689815|
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|NPMc+ AML||Drug: Oral Arsenic Trioxide Formulation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurable-residual Disease (MRD) Monitoring of Nucleophosmin 1 (NPM1)-Mutated Acute Myeloid Leukaemia (AML) and Pre-emptive Therapy With Oral Arsenic Trioxide-based Regimen|
|Estimated Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Oral arsenic trioxide-Azacitidine
12 monthly cycles of oral arsenic trioxide (oral-As2O3) (Arsenol ®) (5-10mg per day, from days 1-7 per cycle), ascorbic acid (1g per day, from days 1 - 7 per cycle) plus azacitidine (75mg/m2 per day subcutaneously, from days 1 to 3 per cycle).
Drug: Oral Arsenic Trioxide Formulation
Eligible subjects with NPM1 MRD positivity will receive oral arsenic trioxide (oral-As2O3) (Arsenol ®) (5-10mg per day, from days 1-7 per cycle), ascorbic acid (1g per day, from days 1 - 7 per cycle) plus azacitidine (75mg/m2 per day subcutaneously, from days 1 to 3 per cycle). Each cycle of oral-As2O3 plus azacitidine will be given once every 28 days. The total duration of treatment is 12 months (12 cycles). Treatment will be day-care and outpatient based. Reduction in the dosage and duration of oral-As2O3 is required if the subject is experiencing adverse events (AEs). In case of grade 3 or above toxicity, the dosage of oral-As2O3 will be reduced to 5mg per day.
Other Name: Arsenol
- Rate of NPM1 MRD negativity. [ Time Frame: 36 months ]This is defined as undetectable NPM1 mutant transcript with RQ-PCR on both the PB and BM following treatment, at a limit of detection of 10^-5.
- Duration of response [ Time Frame: 36 months ]defined as the time from achievement of undetectable NPM1 MRD to Documented molecular recurrence (defined as detectable MRD on PB or BM at a limit of detection of 10^5.
- Leukaemia-free survival (LFS) [ Time Frame: 36 months ]This is defined as the time, in months, from the start of oral-As2O3 plus azacitidine to morphologic relapse of AML.
- Safety of oral-As2O3 plus azacitidine, assessed using the common toxicity criteria for adverse events (CTCAE) version 5.0. [ Time Frame: 36 months ]The incidence of treatment emergent adverse events will be determined as a measure of safety
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): NCT04689815
|Contact: Harinder Gill, MD||+852 firstname.lastname@example.org|
|The University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Harinder Gill, MD 85222554542 email@example.com|
|Sub-Investigator: Yok-Lam Kwong, MD|
|Principal Investigator:||Harinder Gill||The University of Hong Kong|