Status:
UNKNOWN
Oral Arsenic Trioxide for NPM1-mutated AML
Lead Sponsor:
The University of Hong Kong
Conditions:
NPMc+ AML
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A prospective open-label phase 2 study will be designed to assess the efficacy of oral arsenic trioxide plus azacitidine in preventing relapses in patients with NPM1-mutant AML. After screening and el...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years
- Diagnosis of AML with NPM1 mutation
- Positive MRD for NPM1 mutation after completion of consolidation in transplant-ineligible patients
- Positive MRD for NPM1 mutation after allogeneic HSCT
- bilirubin ≤ 1.5 x upper limit normal (ULN); alanine aminotransferase (ALT) ≤ 2 x ULN or aspartate aminotransferase (AST) ≤ 2 x ULN; and prothrombin time versus control \<3 seconds at screening
- Glomerular filtration rate ≥ 50 mL/min (by MDRD equation or Cockcroft-Gault formula)
- Corrected QT interval (QTc) (by Framingham formula) \<500ms.
- Able to give a written informed consent and fully comply to the requirements of the study.
Exclusion
- Patients on other investigational therapies
- Prior exposure to azacitidine, decitabine or arsenic trioxide
- Uncontrolled graft-versus-host disease (GVHD)
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04689815
Start Date
January 1 2021
End Date
December 31 2024
Last Update
October 4 2022
Active Locations (1)
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1
The University of Hong Kong
Hong Kong, Hong Kong