A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

June 4, 2026 updated by: Dizal Pharmaceuticals

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

218

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Ding
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Zhai
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Jing
      • Beijing, Beijing Municipality, China, 100005
        • Recruiting
        • Beijing Hospital
        • Contact:
          • Liu
      • Beijing, Beijing Municipality, China, 100051
        • Recruiting
        • Beijing Tongren Hospital, CMU
        • Contact:
          • Wang
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Wang
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Wu
      • Xiamen, Fujian, China, 361026
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Xu
    • Gansu
      • Lanzhou, Gansu, China, 730013
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
          • Xi
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
          • Cui
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Cai
      • Guangzhou, Guangdong, China, 510210
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Li
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Cen
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Zhang
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Zhou
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Ma
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Zhou
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Wu
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Zhou
      • Wuhan, Hubei, China, 430048
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Zhang
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Zhou
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Xu
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
          • Bai
    • Liaoning
      • Shenyang, Liaoning, China, 110134
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Contact:
          • Yang
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital & Institution
        • Contact:
          • Li
      • Linyi, Shandong, China, 276304
        • Recruiting
        • LinYi Cancer Hospital
        • Contact:
          • Zheng
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
        • Contact:
          • Zhao
      • Shanghai, Shanghai Municipality, China, 200065
        • Recruiting
        • Tongji Hospital of Tongji University
        • Contact:
          • Xiu
    • Shanxi
      • Taiyuan, Shanxi, China, 30013
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Su
      • Xi’an, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • He
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
        • Contact:
          • Huang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Zhang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Yang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Tong
      • Jinhua, Zhejiang, China, 321000
        • Recruiting
        • Jinhua Municipal Centeral Hospital
        • Contact:
          • Zhang
      • Wenzhou, Zhejiang, China, 325015
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Jiang
  • Taiwan
      • Changhua, Taiwan, 00505
        • Recruiting
        • Chang Bing Show Chwan Memorial Hospital
        • Contact:
          • Chang
      • Kaohsiung City, Taiwan, 00833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
          • Wang
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital
        • Contact:
          • Hsieh
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Yeh
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Chen
      • Tainan, Taiwan, 00736
        • Recruiting
        • Chi Mei Medical Center - Liouying Branch
        • Contact:
          • Hsiao
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Hou
      • Taipei, Taiwan, 11259
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center
        • Contact:
          • Tan
  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
          • Uaprasert
      • Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital
        • Contact:
          • Prayongratana
      • Bangkok, Thailand, 10400
        • Recruiting
        • Mahidol University - Faculty of Medicine - Ramathibodi Hospital
        • Contact:
          • Chantrathammachart
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital - Mahidol University
        • Contact:
          • Khuhapinant
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital
        • Contact:
          • Norasetthada
      • Hat Yai, Thailand, 90110
        • Recruiting
        • Prince of Songkla University-Faculty of Medicine
        • Contact:
          • Julamanee
      • Khon Kaen, Thailand, 40002
        • Not yet recruiting
        • Srinagarind Hospital - Faculty of Medicine Khon Kaen University
        • Contact:
          • Wanitpongpun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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 severe cardiac or pulmonary abnormalities
  • Disease condition requires 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Investigator's Choice
Drug: Chidamide
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
Drug: Gemcitabine
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
Experimental: Golidocitinib
Drug: Golidocitinib
150 mg, orally, once daily, with or without food, in a 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: The time from randomization to death due to any cause. Approximately 4 years.
The time from randomization to death due to any cause. Approximately 4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dizal Pharmaceuticals

Investigators

  • Principal Investigator: Zhao, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DZ2022J0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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