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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06630091 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages