OncoMatch/Clinical Trials/NCT07414758
Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy
Is NCT07414758 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies golidocitinib for peripheral t cell lymphoma.
Treatment: golidocitinib — This is a multicenter, randomized, double-blind, phase III clinical study comprising two arms: a golidocitinib group and a placebo group. The study aimed to evaluate the antitumor efficacy and safety of golidocitinib in patients who had achieved a response after first-line systemic therapy and were ineligible for hematopoietic stem cell transplantation. The investigational intervention consisted of either golidocitinib or matching placebo capsules, administered orally at a planned dose of 150 mg once every other day. Treatment continued until disease progression, initiation of new anti-lymphoma therapy, withdrawal of informed consent, death, or investigator decision to discontinue the study, whichever occurred first. The study treatment period was divided into 28-day cycles starting from the first dose. Efficacy and safety assessments were performed at specified time points within each cycle. The maximum duration of treatment was 2 years. A total of 136 patients were enrolled, with 68 patients assigned to the golidocitinib treatment group and 68 to the placebo control group. Data on demographics and medical history were collected, and assessments including vital signs, physical examination, and PET-CT were conducted.
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: systemic standard chemotherapy (CHOP, BV-CHP, CHOP-like regimens) — first-line
Subjects must have achieved a Complete Response (CR) or Partial Response (PR) as assessed by the Lugano 2014 criteria following first-line systemic standard therapy (limited to CHOP, BV-CHP, or CHOP-like regimens)
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: antitumor monoclonal antibody (brentuximab vedotin)
Received antitumor monoclonal antibody therapy (including brentuximab vedotin) within 4 weeks
Cannot have received: antitumor immunotherapy
Received antitumor immunotherapy (e.g., immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, anti-CTLA-4) within 28 days prior to the first study dose
Cannot have received: cytotoxic chemotherapy
Has not discontinued cytotoxic chemotherapy agents for at least 21 days prior to the first study dose
Cannot have received: toxin/radioisotope-immunoconjugate therapy
other toxin/radioisotope-immunoconjugate therapy within 10 weeks prior to the first study dose
Cannot have received: radiation therapy
radiotherapy within 3 weeks
Cannot have received: investigational or antitumor drugs
Received any investigational or antitumor drugs in another clinical trial within 30 days prior to the first study dose
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L (≥1.0 × 10⁹/L if bone marrow involvement); Platelet count ≥100 × 10⁹/L (≥75 × 10⁹/L if bone marrow involvement); Hemoglobin ≥10 g/dL
Kidney function
Serum creatinine ≤1.5 × ULN, OR calculated or measured creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min, OR a 24-hour urine collection demonstrating a creatinine clearance ≥50 mL/min
Liver function
Total bilirubin ≤2 × ULN; ALT and AST ≤2.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiogram (ECHO)
Adequate bone marrow and organ function, as defined below: 1. ANC ≥1.5 × 10⁹/L (≥1.0 × 10⁹/L in case of bone marrow involvement by lymphoma). Subjects must not have used colony-stimulating factors within 7 days prior to study entry. 2. Platelet count ≥100 × 10⁹/L (≥75 × 10⁹/L in case of bone marrow involvement by lymphoma). Subjects must not have received transfusion or thrombopoietic agents within 7 days prior to study entry. 3. Hemoglobin ≥10 g/dL. 4. Total bilirubin ≤2 × ULN. 5. ALT and AST ≤2.5 × ULN. 6. Serum creatinine ≤1.5 × ULN, OR calculated or measured creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min, OR a 24-hour urine collection demonstrating a creatinine clearance ≥50 mL/min. Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiogram (ECHO).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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