Actively Recruiting
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
Led by Dizal Pharmaceuticals · Updated on 2026-06-08
218
Participants Needed
51
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the anti-tumor effects of golidocitinib compared to investigator's choice treatments in adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). This phase 3, open-label, randomized study includes patients who have confirmed PTCL and have not responded to or tolerated at least one prior systemic therapy. The study focuses on several PTCL subtypes and aims to improve treatment options for this condition. Participants will be randomly assigned to receive either golidocitinib orally once daily in repeated 21-day cycles or one of the investigator's choice treatments, which may include chidamide taken orally twice a week or gemcitabine given intravenously on specific days within 28-day cycles. Treatments continue according to protocol with no masking or blinding involved. During the study, participants will be monitored for progression-free survival as the primary outcome, measured from the date of randomization until disease progression or death, over approximately four years. Secondary outcomes like overall survival will also be tracked. Eligibility assessments, compliance with contraceptive requirements, organ function tests, and ongoing safety monitoring will be part of the participant involvement throughout the study duration.
CONDITIONS
Brief Title
A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must sign informed consent and agree to follow study requirements
- Age 18 years or older
- ECOG performance status 0 to 2 with life expectancy of at least 12 weeks
- Histologically confirmed peripheral T-cell lymphoma of specific subtypes
- Disease progressed on, refractory to, or intolerant of at least one prior systemic therapy
- Adequate bone marrow and organ function
- Willingness to follow contraceptive guidelines
You will not qualify if you...
- Previous or current treatments not allowed by the study protocol
- Unresolved drug-related side effects greater than grade 2
- Lymphoma involvement in the central nervous system
- Severe cardiac or pulmonary abnormalities
- Conditions requiring immunosuppressants, biologics, or NSAIDs
- Active infection
- Any cancer diagnosed within the past five years
- Poorly controlled gastrointestinal disorders or medication absorption issues
- Severe or uncontrolled systemic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 years or until disease progression or discontinuation
Participants receive either Golidocitinib or Investigator's Choice treatment for relapsed/refractory peripheral T-cell lymphoma in repeated 21-day or 28-day cycles.
Visits aligned with treatment cycles; frequency depends on assigned treatment
Duration - Up to approximately 4 years from randomization
Participants are monitored for overall survival and long-term outcomes after treatment ends.
Periodic visits for survival assessment
Trial Site Locations
Total: 51 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
3
Beijing Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
4
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China, 100051
Actively Recruiting
5
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
7
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
Actively Recruiting
8
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361026
Actively Recruiting
9
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730013
Actively Recruiting
10
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
11
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
12
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510210
Actively Recruiting
13
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530200
Actively Recruiting
14
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
15
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
16
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
17
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
18
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430048
Actively Recruiting
19
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
20
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
21
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
22
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
23
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
24
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110134
Actively Recruiting
25
Shandong Cancer Hospital & Institution
Jinan, Shandong, China, 250117
Actively Recruiting
26
Linyi Cancer Hospital
Linyi, Shandong, China, 276304
Actively Recruiting
27
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
28
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
29
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 30013
Actively Recruiting
30
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
31
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
32
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
33
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
34
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
35
Jinhua Municipal Centeral Hospital
Jinhua, Zhejiang, China, 321000
Actively Recruiting
36
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Actively Recruiting
37
Chang Bing Show Chwan Memorial Hospital
Changhua, Taiwan, 00505
Actively Recruiting
38
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 00833
Actively Recruiting
39
Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Actively Recruiting
40
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
41
Chi Mei Medical Center - Liouying Branch
Tainan, Taiwan, 00736
Actively Recruiting
42
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
43
National Taiwan University Hospital
Taipei, Taiwan, 10048
Actively Recruiting
44
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 11259
Actively Recruiting
45
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Actively Recruiting
46
Mahidol University - Faculty of Medicine - Ramathibodi Hospital
Bangkok, Thailand, 10400
Actively Recruiting
47
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Actively Recruiting
48
Siriraj Hospital - Mahidol University
Bangkok, Thailand, 10700
Actively Recruiting
49
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
50
Prince of Songkla University-Faculty of Medicine
Hat Yai, Thailand, 90110
Actively Recruiting
51
Srinagarind Hospital - Faculty of Medicine Khon Kaen University
Khon Kaen, Thailand, 40002
Not Yet Recruiting
Research Team
L
Ling Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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