Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04251754
Status:
RECRUITING
Last Update Posted:
2022-10-04
First Post:
2020-01-30
Brief Title:
The Acute Promyelocytic Leukaemia Asian Consortium APL-AC Project
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
The Acute Promyelocytic Leukaemia Asian Consortium APL-AC Project
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:
There is currently lack of collaborative data on the epidemiology clinicopathologic features and treatment outcome of newly diagnosed and relapsed APL in Asia In addition there is lack of data comparing oral- As2O3-based regimens with other treatment approaches including intravenous As2O3in the frontline or relapsed setting With the long-term data of oral-As2O3 based regimen for APL available from Hong Kong retrospective and prospective comparison with other treatment approaches in other Asian countries will generate important information to pave the way for widespread application of oral-As2O3 outside Hong Kong
Detailed Description:
Acute promyelocytic leukemia APL is characterized by t1517q2421 and the fusion gene PML-RARA1 In newly-diagnosed patients optimal supportive care together with the use of all-trans retinoic acid ATRA and chemotherapy results in first complete remission CR1 in excess of 90 with durable remissions in about 80 of patientsArsenic trioxide As2O3 given intravenously iv-As2O3 is highly efficacious for APL in first relapse R1 inducing second complete remission CR2 in more than 90 of patients We have formulated an oral preparation of As2O3 oral-As2O3 and shown that it is efficacious for APL in R1 giving CR2 rates of more than 90 in both adults and children For patients in CR2 a 2-year maintenance with oral-As2O3 results in durable remission and long-term survivals in more than 60 and 70 of patients respectively strongly suggesting that hematopoietic stem cell transplantation HSCT could be obviated in such patients With these results we implemented oral-As2O3 maintenance in CR1 in Hong Kong and demonstrated very favourable overall-survival OS and leukemia-free-survival LFS This implied that that prolonged oral-As2O3 treatment may prevent relapses
Meanwhile iv-As2O3 has also been tested in the frontline treatment of newly-diagnosed APLThese studies employed different strategies recruiting a mixture of low- intermediate- to high-risk patients and placing iv-As2O3 in induction andor consolidation During induction iv-As2O3 was combined with ATRA with additional gemtuzumab ozogamicin an anti-CD33 immunoconjugate or chemotherapy During consolidation iv-As2O3 was combined with conventional chemotherapy Their results all indicated that frontline use of iv-As2O3 in induction andor consolidation improved the outcome of newly-diagnosed APL patients However with quite diverse protocols and the enrollment in some studies of only patients with low to intermediate risks and in other studies of patients with all risk categories the optimal strategy of employing iv-As2O3 in newly-diagnosed APL remains to be defined We have tested oral- As2O3 in combination with ATRA ascorbic acid AAA with daunorubicin in both low-risk and high-risk APL with 3 year LFS and OS of both 100
With the impressive results of oral-As2O3-based regimen in newly diagnosed and relapsed APL an important future perspective is the application of this relatively economical and convenient approach to the treatment of patients with APL in Asia and other developing countries around the world where the cost and availability of intravenous formulation of As2O3 is a concern There is currently lack of collaborative data on the epidemiology clinicopathologic features and treatment outcome of newly diagnosed and relapsed APL in Asia In addition there is lack of data comparing oral- As2O3-based regimens with other treatment approaches including intravenous As2O3in the frontline or relapsed setting With the long-term data of oral-As2O3 based regimen for APL available from Hong Kong retrospective and prospective comparison with other treatment approaches in other Asian countries will generate important information to pave the way for widespread application of oral-As2O3 outside Hong Kong
Meanwhile iv-As2O3 has also been tested in the frontline treatment of newly-diagnosed APLThese studies employed different strategies recruiting a mixture of low- intermediate- to high-risk patients and placing iv-As2O3 in induction andor consolidation During induction iv-As2O3 was combined with ATRA with additional gemtuzumab ozogamicin an anti-CD33 immunoconjugate or chemotherapy During consolidation iv-As2O3 was combined with conventional chemotherapy Their results all indicated that frontline use of iv-As2O3 in induction andor consolidation improved the outcome of newly-diagnosed APL patients However with quite diverse protocols and the enrollment in some studies of only patients with low to intermediate risks and in other studies of patients with all risk categories the optimal strategy of employing iv-As2O3 in newly-diagnosed APL remains to be defined We have tested oral- As2O3 in combination with ATRA ascorbic acid AAA with daunorubicin in both low-risk and high-risk APL with 3 year LFS and OS of both 100
With the impressive results of oral-As2O3-based regimen in newly diagnosed and relapsed APL an important future perspective is the application of this relatively economical and convenient approach to the treatment of patients with APL in Asia and other developing countries around the world where the cost and availability of intravenous formulation of As2O3 is a concern There is currently lack of collaborative data on the epidemiology clinicopathologic features and treatment outcome of newly diagnosed and relapsed APL in Asia In addition there is lack of data comparing oral- As2O3-based regimens with other treatment approaches including intravenous As2O3in the frontline or relapsed setting With the long-term data of oral-As2O3 based regimen for APL available from Hong Kong retrospective and prospective comparison with other treatment approaches in other Asian countries will generate important information to pave the way for widespread application of oral-As2O3 outside Hong Kong
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