Golidocitinib Plus CHOP in Newly Diagnosed PTCL
This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts. In the phase I study, a standard "
| Condition(s) | Peripheral T-cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts. In the phase I study, a standard "3+3" design will be used. The primary endpoints of the Phase I study are the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). The primary endpoint of the Phase II study is the complete response rate (CRR) of the golcadotinib combined with CHOP regimen. |
| Who can participate | Inclusion Criteria: * Age between 18 and 70 years; * Histopathologically confirmed diagnosis of PTCL of one of the following subtypes: (1) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); (2) Angioimmunoblastic T-cell lymphoma (AITL); (3) Anaplastic large cell lymphoma (ALCL); or (4) other PTCL subtypes considered eligible by the investigator; * Patients must have at least one measurable lesion according to the Lugano 2014 criteria: For lymph node lesions, the measurable lymph node must have a long diameter \>1.5 cm; for non-lymph node lesions, the measurable extranodal lesion must have a long diameter \>1.0 cm; * ECOG performance status score of 0-3; * Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L, and hemoglob |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Peking Union Medical College Hospital |
| Locations | Beijing, China |
| Start date | 2024-09-01 |
| NCT ID | NCT06739265 |
| Official listing | https://clinicaltrials.gov/study/NCT06739265 |