Peripheral T-cell LymphomaPhase 3NCT07234162
A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)
A Phase 3 study testing Golidocitinib, Chidamide and Gemcitabine in people with Peripheral T-cell Lymphoma, run by Dizal Pharmaceuticals at 51 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Golidocitinib, Chidamide and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 51 sitesin 3 countries
- Study dates
- 13 May 2024to 31 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants should sign the ICF and be able to comply with the relevant requirements 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
Who cannot join
- Any of previous or current treatment prohibited by protocol
- Any unresolved > grade 2 drug-related adverse events
- Lymphoma involving central nervous system
- Any of severe cardiac or pulmonary abnormalities
- Disease condition requires immunosuppressants, biologics, or NSAIDs
- Active infection
Show all 9Show fewer
- Malignancy disease within five years
- Poorly controlled gastrointestinal disorder or inadequate absorption of medication
- Severe or poorly controlled systemic diseases
Trial locations and contacts
51 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 3 countries
China36 sites, 36 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Liu
- Recruiting
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, 100051
Wang
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jing
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin
Bai
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Zhou
- Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Huang
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Wang
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350011
Wu
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Cai
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510210
Li
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Tong
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yang
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Zhang
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Ding
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Zhai
- Recruiting
Shandong Cancer Hospital & Institution
Jinan, Shandong, 250117
Li
- Recruiting
Jinhua Municipal Centeral Hospital
Jinhua, Zhejiang, 321000
Zhang
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730013
Xi
- Recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Cui
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276304
Zheng
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Xu
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200
Cen
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Zhao
- Recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065
Xiu
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110134
Yang
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 30013
Su
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Zhang
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015
Jiang
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zhou
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430048
Zhang
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhou
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Wu
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
He
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361026
Xu
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Zhou
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Ma
Taiwan8 sites, 8 recruiting
- Recruiting
Chang Bing Show Chwan Memorial Hospital
Changhua, 00505
Chang
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 00833
Wang
- Recruiting
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
Hsieh
- Recruiting
China Medical University Hospital
Taichung, 40447
Yeh
- Recruiting
Chi Mei Medical Center - Liouying Branch
Tainan, 00736
Hsiao
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
Chen
- Recruiting
National Taiwan University Hospital
Taipei, 10048
Hou
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 11259
Tan
Thailand7 sites, 7 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Uaprasert
- Recruiting
Mahidol University - Faculty of Medicine - Ramathibodi Hospital
Bangkok, 10400
Chantrathammachart
- Recruiting
Phramongkutklao Hospital
Bangkok, 10400
Prayongratana
- Recruiting
Siriraj Hospital - Mahidol University
Bangkok, 10700
Khuhapinant
- Recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Norasetthada
- Recruiting
Prince of Songkla University-Faculty of Medicine
Hat Yai, 90110
Julamanee
- Not yet recruiting
Srinagarind Hospital - Faculty of Medicine Khon Kaen University
Khon Kaen, 40002
Wanitpongpun
About this study
Official title: 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
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).
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Golidocitinib, Chidamide, Gemcitabine
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolidocitinibDrug
150 mg, orally, once daily, with or without food, in a 21-day cycle
ChidamideDrug
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
GemcitabineDrug
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Golidocitinib | Experimental | Not described Receives: Drug: Golidocitinib |
| Investigator's Choice | Active comparator | Not described Receives: Drug: Chidamide; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014
Measured: 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)
Measured: The time from randomization to death due to any cause. Approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start13 May 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhao, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234162
- Sponsor's protocol ID
- DZ2022J0004
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07234162
- Acronym / sponsor ID
- DZ2022J0004
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib | Experimental | Drug: Golidocitinib |
| Investigator's Choice | Active comparator | Drug: Chidamide, Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participants should sign the ICF and be able to comply with the relevant requirements 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
Key exclusion criteria (9 listed)
- Any of previous or current treatment prohibited by protocol
- Any unresolved > grade 2 drug-related adverse events
- Lymphoma involving central nervous system
- Any of severe cardiac or pulmonary abnormalities
- Disease condition requires immunosuppressants, biologics, or NSAIDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golidocitinib150 mg, orally, once daily, with or without food, in a 21-day cycle | Drug | Golidocitinib |
| Chidamide30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle | Drug | Investigator's Choice |
| Gemcitabine1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle | Drug | Investigator's Choice |
Primary outcome
Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014
Time frame: 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.
1 secondary outcome
Overall survival (OS)
Time frame: The time from randomization to death due to any cause. Approximately 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao principal investigator
Ruijin Hospital
51 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Golidocitinib, Chidamide and Gemcitabine in people with Peripheral T-cell Lymphoma, run by Dizal Pharmaceuticals at 51 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in China, Taiwan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Zhou (021-61095755, ling.zhou@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.