MedPath

AZD4205 in Peripheral T Cell Lymphoma Following First-Line Therapy (JACKPOT26)

Phase 2
Completed
Conditions
Peripheral T-cell Lymphoma
Interventions
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
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
AZD4205 treatmentAZD4205Cohort 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
NameTimeMethod
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
NameTimeMethod
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 product1 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 product1 year

To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

Trial Locations

Locations (23)

The First Affiliated Hospital of Chongqing Medical University

🇨🇳

Chongqing, Chongqing, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

Research Center of Clinical Trials, The Third Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

🇨🇳

Nanchang, Jiangxi, China

Shandong Cancer Hospital & Institution

🇨🇳

Jinan, Shandong, China

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

Scroll for more (13 remaining)
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.