Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04687176
Status:
RECRUITING
Last Update Posted:
2023-05-23
First Post:
2020-12-23
Brief Title:
Frontline Oral Arsenic Trioxide for APL
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia
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:
The investigators have formulated an oral preparation of arsenic trioxide oral-ATO and shown that it is efficacious for APL in R1 inducing CR2 in more than 90 of patients 89 Furthermore in an effort to prevent relapse the investigators have moved oral-ATO 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-ATO may prevent relapses
Current protocols have incorporated iv-ATO in the treatment of newly-diagnosed APL 11-15 For regimens comprising oral-ATO 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-ATO is highly effective and safe in the relapsed and frontline settings 1617
In this study the investigators evaluate the use of oral-ATO and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study
Current protocols have incorporated iv-ATO in the treatment of newly-diagnosed APL 11-15 For regimens comprising oral-ATO 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-ATO is highly effective and safe in the relapsed and frontline settings 1617
In this study the investigators evaluate the use of oral-ATO and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study
Detailed 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 or idarubicin will only be used during induction in patients 65 with presenting white blood cell count WBC 10 x 109L In patients not receiving daunorubicin hydroxyurea if WBC 5 x 109L 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
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
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