GW5282 with golidocitinib versus CHOP for 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 open‑label phase 1/2 program begins with a dose‑escalation phase to determine the maximum tolerated dose of GW5282 given with golidocitinib. After a recommended phase 2 dose is identified, participants will be randomized in a controlled phase to compare the combination regimen against conventional CHOP chemotherapy for preliminary signals of efficacy and safety. The trial enrolls adults with histologically confirmed peripheral T‑cell lymphoma and measurable disease and requires adequate organ function and performance status. The study is conducted at multiple cancer centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent;
2. Adult ≥ 18 years of age;
3. ECOG performance status score ≤ 2;
4. Life expectancy of not less than 12 weeks;
5. Histopathologically confirmed diagnosis of PTCL;
6. Presence of measurable disease;
7. Adequate bone marrow function and vital organ function reserve;
8. Ability to comply with study requirements and to complete study-related procedures;
9. Adequate contraception during participation in the trial.

Exclusion Criteria:

1. Presence of unresolved drug-related adverse events greater than Grade 1;
2. Lymphoma involving the central nervous system;
3. Failure to complete the required washout period for other anti-tumor therapies;
4. Corticosteroid use that does not meet protocol requirements;
5. Major surgery/trauma within a short period, or planned major surgery within a short period;
6. Vaccination with a live vaccine within a short period;
7. Inability to discontinue prohibited medications;
8. Requirement for immunosuppressive agents or biologics due to an underlying disease;
9. Presence of active infection;
10. Significant cardiovascular disease;
11. Presence of gastrointestinal disease that might affect drug intake or absorption;
12. History of other malignancies;
13. Known allergy to the study drug;
14. Other severe or uncontrolled systemic diseases;
15. Personnel with a conflict of interest (e.g., site staff, sponsor employees);
16. Pregnant or breastfeeding women;
17. Inability to comply with protocol requirements.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting
• Chongqing Cancer Hospital
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Guangxi Medical University Cancer Hospital
  Nanning, Guangxi, China Not yet recruiting
• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Not yet recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Jingrun Li
• Email: jingrun.li@dizalpharma.com
• Phone: +86-21-61097800

Similar studies

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

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

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• Golidocitinib versus placebo as maintenance for peripheral T-cell lymphoma

  This trial will test whether taking golidocitinib every other day can help keep peripheral T‑cell lymphoma in remission for adults who responded to first‑line chemotherapy and are not having a stem cell transplant.

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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.