AZD4205 in Peripheral T Cell Lymphoma Following First-Line Therapy (JACKPOT26)
- Registration Number
- NCT06511869
- Lead Sponsor
- Dizal Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AZD4205 treatment AZD4205 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.
- Primary Outcome Measures
Name Time Method Adverse events and serious adverse events (graded by CTCAE version 5.0) 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 Outcome Measures
Name Time Method Cohort 1: Disease Free Survival (DFS) up to 2 years To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
Cohort 2: Progression-free Survival (PFS) up to 2 years To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
Cohort 2: Progression-free Survival (PFS) rate at 1 year from the first dose of investigational product 1 year To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
Cohort 2: Objective Response Rate (ORR) up to 2 years To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
Cohort 2: Duration of Response (DoR) up to 2 years To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
Cohort 1: Disease Free Survival (DFS) rate at 1 year from the first dose of investigational product 1 year To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
Related Research Topics
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Trial Locations
- Locations (21)
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
🇨🇳Hefei, Anhui, China
The Fifth Affiliated Hospital of Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China
Peking university Third Hospital
🇨🇳Beijing, Beijing, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Thechnology
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Shandong Cancer Hospital & Insititution
🇨🇳Jinan, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunan, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Reasearch Center of Clinical Trials, The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China