Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561048
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Soquelitinib vs Standard of Care in Participants With RelapsedRefractory Peripheral T-cell Lymphoma Not Otherwise Specified Follicular Helper T-cell Lymphomas or Systemic Anaplastic Large-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physicians Choice Standard of Care Treatment Selected Single Agent in Participants With RelapsedRefractory Peripheral T-cell Lymphoma Not Otherwise Specified Follicular Helper T-cell Lymphomas or Systemic Anaplastic Large-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
A Phase 3 randomized 2-arm open-label multicenter stratified study of soquelitinib versus physicians choice standard of care SOC treatment selected single agents in participants with relapsedrefractory RR peripheral T-cell lymphoma not otherwise specified PTCL-NOS follicular helper T-cell lymphomas FHTCLs or systemic anaplastic large-cell lymphoma sALCL
Detailed Description:
This is a Phase 3 randomized 2-arm open-label multicenter stratified study of soquelitinib an oral interleukin-2-inducible T cell kinase ITK inhibitor versus physicians choice standard of care SOC treatment of either belinostat or pralatrexate in participants with relapsedrefractory RR peripheral T-cell lymphoma not otherwise specified PTCL-NOS follicular helper T-cell lymphomas FHTCLs or systemic anaplastic large-cell lymphoma sALCL Approximately 150 participants will be randomized at a 11 ratio to the 2 treatment arms soquelitinib or SOC and will be stratified by region of the world age and time to relapse for the most recent prior therapy Participants will receive study treatment for up to a maximum of 2 years unacceptable toxicity or disease progression whichever is earlier Participants randomized to receive SOC who have confirmation of progressive disease may have the opportunity to crossover to receive treatment with soquelitinib
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