Golidocitinib versus physician-selected therapy for relapsed/refractory peripheral T‑cell lymphoma (Phase 3 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
This Phase 3 test compares golidocitinib with treatments chosen by a doctor to see if it better controls disease in adults with relapsed or refractory peripheral T‑cell lymphoma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dizal Pharmaceuticals Industry-sponsored |
| Drugs / interventions | golidocitinib |
| Locations | 50 sites (Hefei, Anhui and 49 other locations) |
| Trial ID | NCT07234162 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open‑label Phase 3 trial that compares the oral agent golidocitinib to investigator‑chosen chemotherapy or targeted agents in adults with relapsed or refractory peripheral T‑cell lymphoma (PTCL). Eligible patients must have histologically confirmed PTCL of specified subtypes and have progressed on, been refractory to, or been intolerant of at least one prior systemic therapy. Participants are randomized to receive golidocitinib or one of several physician‑selected options such as chidamide, pralatrexate, gemcitabine, or belinostat. The study uses standard anti‑tumor efficacy and disease‑control endpoints to determine whether golidocitinib provides improved clinical benefit.
Who should consider this trial
Good fit: Adults aged 18 or older with histologically confirmed PTCL of the eligible subtypes who have relapsed after, been refractory to, or are intolerant of at least one prior systemic regimen, with ECOG performance status 0–2 and life expectancy of at least 12 weeks, are ideal candidates.
Not a fit: Patients with newly diagnosed disease, non‑eligible lymphoma subtypes, ECOG >2, life expectancy under 12 weeks, or those unable to receive the protocol therapies are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, golidocitinib could offer a more effective treatment option that improves response rates or delays disease progression for patients with relapsed or refractory PTCL.
How similar studies have performed: Some earlier‑phase studies of targeted agents and HDAC inhibitors have shown activity in PTCL, but randomized Phase 3 evidence comparing new agents to physician‑chosen options is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Hefei, Anhui and 49 other locations
- Anhui Provincial Cancer Hospital — Hefei, Anhui, China (Recruiting)
- The Second Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
- Beijing Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Tongren Hospital, CMU — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
- The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
- Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Recruiting)
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
- Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
- The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- Shandong Cancer Hospital & Institution — Jinan, Shandong, China (Recruiting)
- Linyi Cancer Hospital — Linyi, Shandong, China (Recruiting)
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
- The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
- Jinhua Municipal Centeral Hospital — Jinhua, Zhejiang, China (Recruiting)
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
- Chang Bing Show Chwan Memorial Hospital — Changhua, Taiwan (Recruiting)
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- Taipei Medical University - Shuang Ho Hospital — New Taipei City, Taiwan (Recruiting)
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- Chi Mei Medical Center - Liouying Branch — Tainan, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan (Recruiting)
- King Chulalongkorn Memorial Hospital — Bangkok, Thailand (Recruiting)
- Mahidol University - Faculty of Medicine - Ramathibodi Hospital — Bangkok, Thailand (Recruiting)
- Phramongkutklao Hospital — Bangkok, Thailand (Recruiting)
- Siriraj Hospital - Mahidol University — Bangkok, Thailand (Recruiting)
- Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand (Recruiting)
- Prince of Songkla University-Faculty of Medicine — Hat Yai, Thailand (Recruiting)
Study contacts
- Principal investigator: Zhao — Ruijin Hospital
- Study coordinator: Ling Zhou
- Email: ling.zhou@dizalpharma.com
- Phone: 021-61095755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.