Golidocitinib versus placebo as maintenance for peripheral T-cell lymphoma

Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma in Complete or Partial Remission After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind Phase III Clinical Study.

This trial will test whether taking golidocitinib every other day can help keep peripheral T‑cell lymphoma in remission for adults who responded to first‑line chemotherapy and are not having a stem cell transplant.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: brentuximab, chemotherapy, immunotherapy, prednisone, golidocitinib
• Locations: 1 site (Shanghai)
• Trial ID: NCT07300514 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, placebo‑controlled phase III trial that enrolls adults with specific subtypes of peripheral T‑cell lymphoma who achieved a complete or partial response after first‑line CHOP/CHOP‑like or BV‑CHP chemotherapy and who are ineligible for or decline hematopoietic stem cell transplant. Participants are randomized 1:1 to oral golidocitinib 150 mg every other day or matching placebo in 28‑day cycles for up to 24 months, with stratification by initial response, histologic subtype, and HSCT eligibility. Tumor response and progression will be monitored by imaging per Lugano 2014 criteria and treatment continues until progression, unacceptable toxicity, start of new therapy, withdrawal, or study end. Safety and efficacy outcomes will determine whether maintenance JAK1 inhibition reduces relapse rates in this population.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed PTCL subtypes (PTCL‑NOS excluding primary cutaneous disease, ALK‑ALCL, AITL, or PTCL‑TFH) who achieved CR or PR after first‑line systemic chemotherapy and are ineligible for or decline HSCT.

Not a fit: Patients with primary cutaneous PTCL, those with progressive disease after first‑line therapy, or those with significant uncontrolled comorbidities are unlikely to benefit from this maintenance approach.

Why it matters

Potential benefit: If successful, golidocitinib could prolong remission and reduce the risk of relapse for PTCL patients who cannot or choose not to undergo stem cell transplantation.

How similar studies have performed: Prior phase I/II studies of golidocitinib reported encouraging antitumor activity and a tolerable safety profile in relapsed/refractory PTCL, but randomized maintenance data are limited.

Eligibility criteria

Inclusion Criteria:

* Signed written informed consent prior to any study-specific procedures and willingness to comply with all study requirements.
* Age ≥18 years at the time of informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 without deterioration within 2 weeks before screening.
* Histologically confirmed PTCL according to the 2016 WHO classification, limited to the following subtypes: PTCL-not otherwise specified (excluding primary cutaneous PTCL), ALK-positive anaplastic large cell lymphoma (ALK-ALCL), angioimmunoblastic T-cell lymphoma (AITL), or T-follicular helper phenotype PTCL (FTCL or PTCL-TFH).
* Achieved complete response (CR) or partial response (PR) after first-line systemic standard chemotherapy with CHOP, BV-CHP, or CHOP-like regimens, as assessed by Lugano 2014 criteria; patients must be ineligible for HSCT (age \>65 years) or eligible but decline HSCT (age ≤65 years). The interval between completion of first-line therapy and planned first dose in this study must be ≤3 months.
* Adequate bone marrow and organ function, including:

  * Absolute neutrophil count (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× upper limit of normal (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.
  * Willingness and ability to comply with study procedures and follow-up.

Exclusion Criteria:

* Ann Arbor stage I disease at initial diagnosis.
* Prior treatments that could interfere with study therapy, including but not limited to:

  * Investigational agents or antineoplastic drugs within 30 days before first study dose.
  * Cytotoxic chemotherapy within 21 days before first study dose.
  * Systemic corticosteroids at a prednisone-equivalent dose \>10 mg/day within 7 days before first study dose.
  * Major surgery (excluding vascular access procedures) or severe trauma within 4 weeks before first study dose, or planned surgery during study treatment.
  * Antineoplastic monoclonal antibodies (including brentuximab vedotin) within 4 weeks before first study dose; radiotherapy within 3 weeks; other toxin- or radioisotope-conjugated antibodies within 10 weeks.
  * Prior treatment with any JAK or STAT3 inhibitor.
  * Antitumor immunotherapy (e.g., immune checkpoint inhibitors including PD-1, PD-L1, CTLA-4 antibodies) within 28 days before first study dose.
  * Live attenuated or viral vector vaccines within 28 days before first study dose.
  * Current use of vitamin K antagonists, antiplatelet or anticoagulant drugs that cannot be discontinued ≥7 days before first study dose.
  * Concomitant medications that are strong CYP3A inducers or inhibitors, or BCRP/P-gp substrates with narrow therapeutic index that cannot be stopped ≥7 days before first study dose, as specified in the protocol appendix.
* Active hepatitis C infection (positive anti-HCV antibody).
* Hepatitis B virus (HBV) DNA ≥1000 IU/mL or other HBV status not meeting protocol-defined criteria for safe inclusion.
* Known HIV infection with confirmed positive serology.
* Any uncontrolled, clinically significant comorbidities or laboratory abnormalities that, in the investigator's judgment, would increase risk or interfere with study participation.
* History of drug-induced interstitial lung disease or current evidence of clinically significant interstitial lung disease.
* Pregnant or breastfeeding women; women of childbearing potential and men with fertile partners who are unwilling or unable to use effective contraception during treatment and for the protocol-specified period after the last dose.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Rong Tao, MD &PhD — Fudan University
• Study coordinator: Rong Tao, MD & PhD

Conditions Maintenance Treatment of Peripheral T-cell Lymphoma; Peripheral T-cell lymphoma; ALK-positive anaplastic large cell lymphoma; Angioimmunoblastic T-cell lymphoma; TFH phenotype PTCL; Golidocitinib; JAK1 inhibitor; Maintenance therapy