An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of Selinexor in the Maintenance Treatment of PTCL

Sponsor
The First Hospital of Jilin University
Study ID
NCT05822050
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • PTCL Patients Who Achieved Complete Response From Frontline Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To evaluate the efficacy and safety of Selinexor maintenance therapy in PTCL patients who achieved complete response from frontline treatment, and to analyze the relationship between gene mutation in PTCL and disease prognosis and clinical features by using Next-generation sequencing (NGS) detection.

Key Dates

Start date
Jun 1, 2023
Status verified
Aug 2023
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Low risk group
    10 patients. Selinexor 60mg QW Oral 21days/cycle
  • Experimental: Medium/High risk group
    10 patients. Selinexor 60mg QW Oral with Chemotherapy 21days/cycle

Primary Outcome Measure

Progression Free Survival rate of 1 year (1y PFS rate) [ Time Frame: 1 year from the start of selinexor treatment ]

Central Contacts