Golidocitinib versus physician-selected therapy for relapsed/refractory peripheral T‑cell lymphoma (Phase 3 JACKPOT19)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Zhao — Ruijin Hospital
• Study coordinator: Ling Zhou
• Email: ling.zhou@dizalpharma.com
• Phone: 021-61095755

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests whether taking golidocitinib every other day can help keep peripheral T‑cell lymphoma from coming back in adults who responded to first‑line chemotherapy but cannot have a stem cell transplant.

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• Golidocitinib with liposomal mitoxantrone or chidamide for relapsed or refractory peripheral T‑cell lymphoma

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• Evaluating Golidocitinib for Newly Diagnosed Peripheral T Cell Lymphoma

  This study is testing a new drug called golidocitinib to see if it can help people with newly diagnosed peripheral T cell lymphoma live longer without their cancer getting worse.

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• Non-Hodgkin Lymphoma Sample Collection for MRD Testing

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  Recruiting Natera, Inc. · Austin, Texas · NCT07750886

• XNW5004 with CHOP/CHOEP in Untreated Peripheral T-Cell Lymphoma

  This study tests XNW5004 together with CHOP or CHOEP in adults with newly diagnosed peripheral T-cell lymphoma to see if the combination is safe and active.

  Recruiting Phase 1/2 Evopoint Biosciences Inc. · Shanghai, Shanghai Municipality · NCT07730515

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.