OncoMatch/Clinical Trials/NCT06630091
A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study
Is NCT06630091 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for peripheral t cell lymphoma.
Treatment: Golidocitinib · Cyclophosphamide · Doxorubicin · Vincristine · Prednisone — To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational anti-cancer agent
Any investigational anti-cancer agents or anti-cancer study drugs from a previous clinical study
Cannot have received: cytotoxic chemotherapy
Any cytotoxic chemotherapy from a previous treatment regimen
Cannot have received: JAK inhibitor
Prior treatment with a JAK or STAT3 inhibitor
Cannot have received: STAT3 inhibitor
Prior treatment with a JAK or STAT3 inhibitor
Cannot have received: onco-immunotherapy (PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor)
Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of golidocitinib (e.g., immune checkpoint inhibitors PD-1, PD-L1, CTLA4)
Lab requirements
Blood counts
ANC ≥ 1 ×10^9/L (≥0.5 ×10^9/L if documented bone marrow involvement with lymphoma) independent of growth factor support within 7 days of study entry. Platelets ≥ 75 × 10^9/L (or ≥ 50 × 10^9/L if documented bone marrow involvement with lymphoma) independent of growth factor support or transfusion within 7 days of study entry. Hemoglobin ≥ 8 g/dL.
Kidney function
Creatinine ≤ 1.5 × ULN, OR calculated or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method, or 24-hour measured urine creatinine clearance ≥ 50 mL/min.
Liver function
Total bilirubin ≤ 1.5 ×ULN if no liver involvement or ≤ 3 ×ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver involvement. ALT and AST ≤ 2.5 × ULN, or ≤ 5 ×ULN if with document hepatic involvement with lymphoma.
Cardiac function
LVEF ≥ 50% assessed by ECHO or MUGA.
Adequate bone marrow reserve and organ system functions, as outlined below: ANC ≥ 1 ×10^9/L (≥0.5 ×10^9/L if documented bone marrow involvement with lymphoma) independent of growth factor support within 7 days of study entry. Platelets ≥ 75 × 10^9/L (or ≥ 50 × 10^9/L if documented bone marrow involvement with lymphoma) independent of growth factor support or transfusion within 7 days of study entry. Hemoglobin ≥ 8 g/dL. Total bilirubin ≤ 1.5 ×ULN if no liver involvement or ≤ 3 ×ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver involvement. ALT and AST ≤ 2.5 × ULN, or ≤ 5 ×ULN if with document hepatic involvement with lymphoma. Creatinine ≤ 1.5 × ULN, OR calculated or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method, or 24-hour measured urine creatinine clearance ≥ 50 mL/min. LVEF ≥ 50% assessed by ECHO or MUGA.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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