Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514534
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant Intolerant or Ineligible to Ponatinib
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Multi-center Prospective Open-label Study of Asciminib in Patients With Chronic Myeloid Leukemia in Chronic Phase CML-CP or Accelerated Phase CML-AP With T315I Mutation Who Are Resistant Intolerant or Ineligible to Ponatinib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASC4TARGET
Brief Summary:
The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation The presence of this mutation introduces treatment difficulties due to the limited available options The study seeks to collect additional data on the effectiveness and safety of asciminib for these patients By determining the drugs capacity to manage the disease and enhance patients outcomes the study is designed to fill the unmet medical need and potentially offer a new therapeutic path for patients at a treatment deadlock
Detailed Description:
This study is a Phase II multi-center single-arm prospective open-label study that aims to evaluate the efficacy and safety of oral asciminib in patients with CML-CP or CML-AP with T315I mutation and after at least one tyrosine kinase inhibitors TKI and are resistant intolerant or ineligible for treatment with ponatinib
Patients who have not been previously treated with asciminib would be enrolled in this study The researchers will assess the effectiveness of asciminib in these participants as well as evaluate its safety profile The study will consist of two phases
The core phase which aims to answer the scientific and medical objectives
An extension phase intended to provide opportunity to the participants to continue their ongoing treatment asciminib up to commercialization in France or decision to not commercialize asciminib for the study population stopping development refusal to extend marketing authorization refusal of reimbursement
Patients who have not been previously treated with asciminib would be enrolled in this study The researchers will assess the effectiveness of asciminib in these participants as well as evaluate its safety profile The study will consist of two phases
The core phase which aims to answer the scientific and medical objectives
An extension phase intended to provide opportunity to the participants to continue their ongoing treatment asciminib up to commercialization in France or decision to not commercialize asciminib for the study population stopping development refusal to extend marketing authorization refusal of reimbursement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None