RecruitingPhase 3NCT07234162

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed/Refractory Peripheral T-cell Lymphoma


Sponsor

Dizal Pharmaceuticals

Enrollment

218 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a targeted drug called golidocitinib against other standard treatments for people with a type of blood cancer called peripheral T-cell lymphoma (a cancer of the immune system's T-cells) that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of peripheral T-cell lymphoma (a specific subtype) - Your cancer has returned or stopped responding to at least one previous treatment - You are in reasonable overall health (able to carry out daily activities) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - You have serious heart or lung problems - You have an active serious infection - You have had another cancer within the last 5 years - You have poorly controlled stomach or intestinal problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGolidocitinib

150 mg, orally, once daily, with or without food, in a 21-day cycle

DRUGChidamide

30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle

DRUGPralatrexate

30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles

DRUGGemcitabine

1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle

DRUGBelinostat

1000 mg/m2, intravenous infusion, administered once daily (QD) on Day 1 to Day 5 of a 21-day cycle


Locations(50)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital & Institution

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Jinhua Municipal Centeral Hospital

Jinhua, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Chang Bing Show Chwan Memorial Hospital

Changhua, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Chi Mei Medical Center - Liouying Branch

Tainan, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Mahidol University - Faculty of Medicine - Ramathibodi Hospital

Bangkok, Thailand

Phramongkutklao Hospital

Bangkok, Thailand

Siriraj Hospital - Mahidol University

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Prince of Songkla University-Faculty of Medicine

Hat Yai, Thailand

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NCT07234162


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