Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy (T-START-M1)

Golidocitinib Versus Placebo as Maintenance Therapy in Peripheral T-Cell Lymphoma Patients With Response (CR/PR) After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: golidocitinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xianmin Song, MD; Phone Number: +862163240090 18616705298; Email: shongxm@139.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Recruiting
      • Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
      • Principal Investigator: Xianmin Song, MD
      • Contact: xianmin Song, MD; Phone Number: +862163240090 18616705298; Email: shongxm@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The subject must sign the informed consent form (ICF) in accordance with the relevant procedures described in the chapter, and be willing and able to comply with the requirements and restrictions listed in the ICF and this study protocol.
• Age >18 years at the time of signing the ICF.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, with no deterioration within the last 2 weeks.
• Histopathologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al., 2016). Eligible histological subtypes are limited to: PTCL-NOS (excluding primary cutaneous), ALK-negative ALCL, AITL, and follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH).
• 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), and are either transplant-ineligible (age >65 years) or transplant-eligible (age ≤65 years) but have provided written refusal for transplantation. The time from the end of initial therapy to the planned first dose in this study must be ≤3 months.

• Adequate bone marrow and organ function, as defined below:

  1. Absolute neutrophil count (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 × Upper Limit of Normal (ULN).
  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (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).
• Voluntarily participate in the clinical study; fully understand and are informed about this study and sign the ICF; willing and able to follow and complete all trial procedures.

Exclusion Criteria:

• Patients with clinical stage Ann Arbor I disease.

• Any of the following treatment histories:

  1. Received any investigational or antitumor drugs in another clinical trial within 30 days prior to the first study dose.
  2. Has not discontinued cytotoxic chemotherapy agents for at least 21 days prior to the first study dose.
  3. Received systemic corticosteroid therapy at a dose >10 mg prednisone equivalent per day within 1 week prior to the first study dose.
  4. Underwent major surgery (excluding vascular access procedures) or experienced significant trauma within 4 weeks prior to the first study dose, or has planned surgery during the study.
  5. Received antitumor monoclonal antibody therapy (including brentuximab vedotin) within 4 weeks; radiotherapy within 3 weeks; or other toxin/radioisotope-immunoconjugate therapy within 10 weeks prior to the first study dose.
  6. Prior treatment with a JAK or STAT3 inhibitor.
  7. 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.
  8. Received live-attenuated or viral vector vaccines within 28 days prior to the first study dose.
  9. Current use (or inability to discontinue ≥1 week prior to the first dose) of vitamin K antagonists, antiplatelet agents, or anticoagulants.

Current use (or inability to discontinue ≥1 week prior to the first dose) of medications, herbal supplements, or foods known to be potent inducers or inhibitors of CYP3A, or sensitive substrates of BCRP/P-gp with a narrow therapeutic index (see Appendix F for guidance on potentially interacting concomitant medications).

• History of other active malignancies within the past 5 years, except for curatively treated localized cancers such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

• Active infection, including:

  1. Known active or latent tuberculosis, evidenced by a positive PPD skin test (>10 mm induration, or per local clinical criteria) or findings suggestive of active/latent TB on chest X-ray/CT.
  2. Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
  3. Chronic active Hepatitis B or C infection, except:
  1. Subjects positive for HBsAg or HBcAb are eligible if HBV-DNA is undetectable.
  2. Subjects positive for HCV antibody are eligible if HCV-RNA is undetectable. (The ULN for HBV-DNA and HCV-RNA assays is defined per each center's laboratory standards.) (d) Other active viral infections (e.g., herpes zoster), cytomegalovirus (CMV), or Epstein-Barr virus (EBV) infection, excluding Hepatitis B and C.

Active infection requiring intravenous antimicrobial therapy, characterized by hemodynamic instability, worsening/new infectious symptoms/signs, new infectious foci on imaging, or persistent fever without other explanation.

• Poorly controlled or clinically significant cardiac disease, such as:

  i. Heart failure > New York Heart Association (NYHA) class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.

• Pregnant or lactating women, or subjects of childbearing potential unwilling to use effective contraception.
• History of severe psychiatric disorders or inability to provide informed consent.
• Subjects with refractory nausea, vomiting, or chronic gastrointestinal diseases that may impair drug absorption.
• Significant impairment of pulmonary function, defined as forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO) <60% of predicted.
• Presence of unresolved drug-related toxicities > Grade 1 per CTCAE (except for alopecia) prior to the first study dose.
• Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: golidocitinib group; This is a patient cohort that receives golidocitinib medicine orally at a planned dose of 150 mg once every other day after first-line therapy with response.	Drug: golidocitinib; Eligible patients were randomized to receive golidocitinib medicine orally at a planned dose of 150 mg once every other day.
Placebo Comparator: placebo group; This is a patient cohort that receives placebo capsules orally at a planned dose of 150 mg once every other day after first-line therapy with response.	Drug: Placebo; Eligible patients were randomized to receive placebo orally at a planned dose of 150 mg once every other day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS means the time from receiving golidocitinib or placebo capsules until the first occurrence of disease progression or death from any cause.	up to 2 years for the 2y-PFS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	The probability of survival at 1 or 2 years, measured from the date of receiving golidocitinib or matching placebo capsules to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.	up to 1 years for the 1y-OS and up to 2 years for the 2y-OS
complete remission rate (CRR)	Complete response rate refers to the proportion of patients who meet the criteria for complete response among all enrolled patients at a specific time point defined by the study.	up to 1 years for the 1y-CRR and up to 2 years for the 2y-CRR
Time to Next Treatment (TTNT)	TTNT is defined as the time from the initiation of the current therapy to the start of any subsequent antineoplastic treatment or death from any cause.	up to 2 years for the TTNT
Duration of Response (DoR)	DOR is defined as the time interval from the date when the patient first meets the criteria for response to the date of the first documented disease progression or death from any cause.	up to 2 years for DoR

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Ruijin Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Cancer Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: interventional; Peripheral T Cell Lymphoma; golidocitinib
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Hemic and Lymphatic Diseases; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: T-START-M1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No