A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)
NCT ID: NCT07234162
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
218 participants
INTERVENTIONAL
2024-05-13
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Golidocitinib
Golidocitinib
150 mg, orally, once daily, with or without food, in a 21-day cycle
Investigator's Choice
Chidamide
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
Pralatrexate
30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles
Gemcitabine
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
Belinostat
1000 mg/m2, intravenous infusion, administered once daily (QD) on Day 1 to Day 5 of a 21-day cycle
Interventions
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Golidocitinib
150 mg, orally, once daily, with or without food, in a 21-day cycle
Chidamide
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
Pralatrexate
30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles
Gemcitabine
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
Belinostat
1000 mg/m2, intravenous infusion, administered once daily (QD) on Day 1 to Day 5 of a 21-day cycle
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* ECOG 0-2 score, life expectancy ≥ 12 weeks
* Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell lymphoma, or PTCL with T-follicular helper (TFH) phenotype (FTCL or PTCL-TFH), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Natural killer/T-cell lymphoma (NK/TCL), Hepatosplenic T-cell lymphoma (HSTCL), Subcutaneous panniculitis-like T-cell lymphoma (SPTCL)
* Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator
* Adequate bone marrow reserve and organ system functions
* Willing to comply with contraceptive restrictions
Exclusion Criteria
* Any unresolved \> grade 2 drug-related adverse events
* Lymphoma involving central nervous system
* Any of serere cardiac or pulmonary abnormalities
* Disease condition requiring immunosuppressants, biologics, or NSAIDs
* Active infection
* Malignancy disease within five years
* Poorly controlled gastrointestinal disorder or inadequate absorption of medication
* Severe or poorly controlled systemic diseases
18 Years
ALL
No
Sponsors
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Dizal Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Zhao
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ding
Role: primary
Zhai
Role: primary
Liu
Role: primary
Wang
Role: primary
Jing
Role: primary
Wang
Role: primary
Wu
Role: primary
Xu
Role: primary
Xi
Role: primary
Cui
Role: primary
Cai
Role: primary
Li
Role: primary
Cen
Role: primary
Zhang
Role: primary
Zhou
Role: primary
Ma
Role: primary
Zhou
Role: primary
Zhang
Role: primary
Zhou
Role: primary
Wu
Role: primary
Zhou
Role: primary
Xu
Role: primary
Bai
Role: primary
Yang
Role: primary
Li
Role: primary
Zheng
Role: primary
Zhao
Role: primary
Xiu
Role: primary
Su
Role: primary
He
Role: primary
Huang
Role: primary
Zhang
Role: primary
Tong
Role: primary
Yang
Role: primary
Zhang
Role: primary
Jiang
Role: primary
Chang
Role: primary
Wang
Role: primary
Hsieh
Role: primary
Yeh
Role: primary
Hsiao
Role: primary
Chen
Role: primary
Hou
Role: primary
Tan
Role: primary
Uaprasert
Role: primary
Chantrathammachart
Role: primary
Prayongratana
Role: primary
Khuhapinant
Role: primary
Norasetthada
Role: primary
Julamanee
Role: primary
Other Identifiers
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DZ2022J0004
Identifier Type: -
Identifier Source: org_study_id
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