OncoMatch/Clinical Trials/NCT07300514
Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma
Is NCT07300514 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PET-CTandct- DNAdetection and golidocitinib for maintenance treatment of peripheral t-cell lymphoma.
Treatment: PET-CTandct- DNAdetection · golidocitinib — This is a multicenter, randomized, double-blind, placebo-controlled phase III trial evaluating golidocitinib as maintenance therapy in adult patients with peripheral T-cell lymphoma (PTCL) who achieved complete response (CR) or partial response (PR) after first-line systemic chemotherapy and are not candidates for hematopoietic stem cell transplantation (HSCT) or decline HSCT. Eligible patients with histologically confirmed PTCL subtypes (PTCL-NOS, ALK-positive anaplastic large cell lymphoma \[ALK-ALCL\], angioimmunoblastic T-cell lymphoma \[AITL\], or follicular helper T-cell phenotype PTCL \[FTCL/PTCL-TFH\]) according to the 2016 WHO classification will be randomized 1:1 to receive oral golidocitinib or matching placebo. Study treatment is given at 150 mg every other day in 28-day cycles for up to 2 years or until disease progression, unacceptable toxicity, start of new anti-lymphoma therapy, withdrawal of consent, or study termination. At 12 months, patients who achieve complete metabolic response on PET-CT and minimal residual disease (MRD)-negative status by ctDNA may discontinue maintenance, whereas others continue treatment up to 24 months. After treatment discontinuation, patients will be followed for disease status and survival for up to approximately 13 additional cycles. The primary endpoint is progression-free survival (PFS) assessed by investigators per Lugano 2014 criteria. Key secondary endpoints include overall survival, response rates, duration of response, time to next anti-lymphoma therapy, MRD dynamics by ctDNA, and safety.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Excluded: Stage I
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy (CHOP, BV-CHP, CHOP-like regimens) — first-line
Achieved complete response (CR) or partial response (PR) after first-line systemic standard chemotherapy with CHOP, BV-CHP, or CHOP-like regimens
Cannot have received: JAK inhibitor
Prior treatment with any JAK or STAT3 inhibitor
Cannot have received: STAT3 inhibitor
Prior treatment with any JAK or STAT3 inhibitor
Cannot have received: antineoplastic monoclonal antibody (brentuximab vedotin)
Antineoplastic monoclonal antibodies (including brentuximab vedotin) within 4 weeks before first study dose
Cannot have received: antitumor immunotherapy
Antitumor immunotherapy (e.g., immune checkpoint inhibitors including PD-1, PD-L1, CTLA-4 antibodies) within 28 days before first study dose
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L (≥1.0×10⁹/L if bone marrow is involved by lymphoma), without use of colony-stimulating factors within 7 days before study entry; Platelet count ≥100×10⁹/L (≥75×10⁹/L if bone marrow is involved by lymphoma), without transfusion or platelet growth factors within 7 days before study entry; Hemoglobin ≥10 g/dL
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated or measured)
Liver function
Total bilirubin ≤2× ULN; ALT and AST ≤2.5×ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50% on echocardiography
Adequate bone marrow and organ function, including: ANC ≥1.5×10⁹/L (≥1.0×10⁹/L if bone marrow is involved by lymphoma), without use of colony-stimulating factors within 7 days before study entry; Platelet count ≥100×10⁹/L (≥75×10⁹/L if bone marrow is involved by lymphoma), without transfusion or platelet growth factors within 7 days before study entry; Hemoglobin ≥10 g/dL; Total bilirubin ≤2× ULN; ALT and AST ≤2.5×ULN; Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated or measured); Left ventricular ejection fraction (LVEF) ≥50% on echocardiography
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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