About this trial
This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.
Eligibility criteria
Qualifiers
Signed informed consent;
Adult ≥ 18 years of age;
ECOG performance status score ≤ 2;
Life expectancy of not less than 12 weeks;
Disqualifiers
Presence of unresolved drug-related adverse events greater than Grade 1;
Lymphoma involving the central nervous system;
Failure to complete the required washout period for other anti-tumor therapies;
Corticosteroid use that does not meet protocol requirements;
Trial design
Treatments tested in this trial
- GW5282 combined with Golidocitinib
- GW5282 combined with Golidocitinib
- Conventional CHOP regimen