Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04689815
Status:
RECRUITING
Last Update Posted:
2022-10-04
First Post:
2020-12-24
Brief Title:
Oral Arsenic Trioxide for NPM1-mutated AML
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eligibility assessment patients will receive treatment with oral arsenic trioxide plus azacitidine for 12 months The recruitment period will last for 24 months and it will take approximately 36 months for study completion
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 plus azacitidine 75mgm2 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 Changes or interruption in dosages their dates and time points will be recorded on the dosage administration record and the electronic case report form eCRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None