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

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 prospective, open‑label phase Ib/II study testing the safety and activity of combining golidocitinib with either mitoxantrone hydrochloride liposome or the HDAC inhibitor chidamide in adults with relapsed or refractory peripheral T‑cell lymphoma. Phase Ib will identify tolerable dose levels and any dose‑limiting toxicities, and phase II will expand cohorts to measure antitumor activity. Responses will be measured using the Lugano 2014 lymphoma criteria and key endpoints include safety, objective response rate, duration of response, and progression‑free survival. Eligible patients must have measurable disease, ECOG 0–2, adequate organ and marrow function, and be able to receive treatment at participating sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
* Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center
* Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion
* Age ≥ 18 years
* Expected survival greater than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate organ and bone marrow function

Exclusion Criteria:

* Accompanied by hemophagocytic lymphohistiocytosis (HLH)
* Lymphoma involvement in the central nervous system or meninges
* Active infections
* Uncontrolled clinical cardiac symptoms or diseases
* Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
* Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment).
* History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
* Patients with mental disorders or those unable to provide informed consent

Where it's running

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qingqing Cai
• Email: caiqq@sysucc.org.cn
• Phone: +862087342823

Similar studies

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

• Golidocitinib versus placebo as maintenance treatment for PTCL patients in remission after first-line chemotherapy

  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.

  Recruiting Phase 3 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07414758

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

  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.

  Recruiting at 50 sites Phase 3 Dizal Pharmaceuticals · Hefei, Anhui and 50 other locations · NCT07234162

• 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.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT06630091

• Golidocitinib and chidamide for cutaneous T-cell lymphoma

  This study tests whether the combo of golidocitinib and chidamide helps people with CTCL that has already received prior systemic therapy.

  Recruiting Phase 1/2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07754890

• Non-Hodgkin Lymphoma Sample Collection for MRD Testing

  This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.

  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.