A Phase II, Open-Label, Multicenter Study to Assess the Safety and Anti-Tumor Efficacy of AZD4205 in Participants With Peripheral T Cell Lymphoma Who Have Responded After First-Line Standard Therapy
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Dizal Pharmaceuticals
- Enrollment
- 48
- Locations
- 23
- Primary Endpoint
- Adverse events and serious adverse events (graded by CTCAE version 5.0)
Overview
Brief Summary
This study is intended to assess the safety and anti-tumor activity of AZD4205 at 150 mg once daily in participants with PTCL who have achieved tumor response after first-line systemic therapy (with or without combination radiotherapy) and are ineligible for HSCT assessed by the investigator as ineligible for HSCT or have no plan for HSCT.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AZD4205 treatment
Cohort 1: Participants achieving a CR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy.
Cohort 2: Participants achieving a PR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy.
Intervention: AZD4205 (Drug)
Outcomes
Primary Outcomes
Adverse events and serious adverse events (graded by CTCAE version 5.0)
Time Frame: up to 2 years
To assess the safety and tolerability of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
Secondary Outcomes
- Cohort 1: Disease Free Survival (DFS)(up to 2 years)
- Cohort 2: Progression-free Survival (PFS)(up to 2 years)
- Cohort 2: Progression-free Survival (PFS) rate at 1 year from the first dose of investigational product(1 year)
- Cohort 2: Objective Response Rate (ORR)(up to 2 years)
- Cohort 2: Duration of Response (DoR)(up to 2 years)
- Cohort 1: Disease Free Survival (DFS) rate at 1 year from the first dose of investigational product(1 year)