AZD4205 in Peripheral T Cell Lymphoma Following First-Line Therapy (JACKPOT26)
NCT Number: NCT06511869
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Peripheral T-cell Lymphoma
Interventions: DRUG: AZD4205
Sponsor: Dizal Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-17
Completion Date: 2026-03
Locations: Anhui Provincial Hospital (The First Affiliated Hospital of USTC), Hefei, Anhui, China|Peking university Third Hospital, Beijing, Beijing, China|Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China|The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China|Hainan General Hospital, Haikou, Hainan, China|The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China|Henan Cancer Hospital, Zhengzhou, Henan, China|Hubei Cancer Hospital, Wuhan, Hubei, China|Union Hospital Tongji Medical College Huazhong University of Science and Thechnology, Wuhan, Hubei, China|Hunan Cancer Hospital, Changsha, Hunan, China|Reasearch Center of Clinical Trials, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China|The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, 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|Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China|Yunnan Cancer Hospital, Kunming, Yunan, China|The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

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.

Primary Outcome Measures: Adverse events and serious adverse events (graded by CTCAE version 5.0), To assess the safety and tolerability of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy, up to 2 years
Secondary Outcome Measures: Cohort 1: Disease Free Survival (DFS), To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy, up to 2 years|Cohort 1: Disease Free Survival (DFS) rate at 1 year from the first dose of investigational product, To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy, 1 year|Cohort 2: Objective Response Rate (ORR), To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy, up to 2 years|Cohort 2: Duration of Response (DoR), To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy, up to 2 years|Cohort 2: Progression-free Survival (PFS), To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy, up to 2 years|Cohort 2: Progression-free Survival (PFS) rate at 1 year from the first dose of investigational product, To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy, 1 year