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
1 other identifier
interventional
218
3 countries
50
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2024
Typical duration for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2024
CompletedFirst Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
November 18, 2025
September 1, 2025
3.6 years
November 14, 2025
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014
The time from the date of randomization to the date of first progressive disease, death due to any cause whichever occurred first. Approximately 4 years.
Secondary Outcomes (1)
Overall survival (OS)
The time from randomization to death due to any cause. Approximately 4 years.
Study Arms (2)
Golidocitinib
EXPERIMENTALInvestigator's Choice
ACTIVE COMPARATORInterventions
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
1000 mg/m2, intravenous infusion, administered once daily (QD) on Day 1 to Day 5 of a 21-day cycle
Eligibility Criteria
You may qualify if:
- The participants should sign the ICF and be able to comply with the relevant requirement in the ICF and protocol
- 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
You may not qualify if:
- Any of previous or current treatment prohibited by protocol
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, 100051, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350011, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361026, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730013, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510210, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430048, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110134, China
Shandong Cancer Hospital & Institution
Jinan, Shandong, 250117, China
Linyi Cancer Hospital
Linyi, Shandong, 276304, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 30013, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Jinhua Municipal Centeral Hospital
Jinhua, Zhejiang, 321000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015, China
Chang Bing Show Chwan Memorial Hospital
Changhua, 00505, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 00833, Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Chi Mei Medical Center - Liouying Branch
Tainan, 00736, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 11259, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Mahidol University - Faculty of Medicine - Ramathibodi Hospital
Bangkok, 10400, Thailand
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Siriraj Hospital - Mahidol University
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Prince of Songkla University-Faculty of Medicine
Hat Yai, 90110, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 18, 2025
Study Start
May 13, 2024
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
October 31, 2028
Last Updated
November 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share