Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma (T-START-M1)

March 28, 2026 updated by: Rong Tao, Fudan University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Peripheral T-cell lymphomas (PTCL) are aggressive non-Hodgkin lymphomas with poor prognosis and high relapse rates after first-line chemotherapy. There is no established standard of care for post-remission maintenance therapy in patients who are not candidates for hematopoietic stem cell transplantation. Aberrant activation of the JAK/STAT pathway plays a critical role in the pathogenesis and progression of PTCL. Golidocitinib (Chinese name: 戈利昔替尼) is an oral, potent, and highly selective JAK1 inhibitor that has demonstrated robust antitumor activity and a favorable safety profile in relapsed or refractory PTCL in prior clinical studies, leading to its recommended phase II dose of 150 mg once daily.

Based on these data and the unmet need for effective maintenance strategies, this phase III study (T-START-M1) will enroll adult patients with histologically confirmed PTCL subtypes (PTCL-NOS excluding primary cutaneous disease, ALK-ALCL, AITL, FTCL/PTCL-TFH) who achieved CR or PR after first-line CHOP, BV-CHP, or CHOP-like regimens and are ineligible for HSCT (age >65 years) or decline HSCT despite eligibility. Randomization (1:1) will be stratified by initial response status (CR vs PR), histologic subtype (ALK-ALCL vs others), and HSCT eligibility (ineligible vs eligible-but-declining).

Participants will receive golidocitinib 150 mg every other day or matching placebo in 28-day cycles for up to 24 months. Tumor response will be assessed by imaging according to Lugano 2014 criteria, and ctDNA-based MRD will be evaluated at baseline, 12 months, and end of treatment. Patients who achieve complete metabolic response plus MRD negativity at 12 months may stop maintenance, while others continue up to 2 years. After treatment discontinuation, patients will be followed for progression, subsequent anti-lymphoma therapies, and survival for up to approximately 13 additional cycles (about 1 year). The primary objective is to determine whether golidocitinib maintenance improves PFS compared with placebo. Key secondary objectives include evaluation of overall survival, complete response rate, duration of response, time to next anti-lymphoma therapy, ctDNA-based MRD dynamics, and safety including incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and grade ≥3 AEs.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rong Tao, MD & PhD
  • Phone Number: 0086-21-64175590
  • Email: rtao@shca.org.cn

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A - Experimental: Golidocitinib
Participants receive golidocitinib 150 mg orally every other day in 28-day cycles for up to 24 months, or until disease progression, unacceptable toxicity, start of new anti-lymphoma therapy, withdrawal of consent, or study termination.
Device: PET-CTandct- DNAdetection
The patients who achieved CMR by PET-CT and MRD-neg by ct-DNA testing were evaluated at 12 months,One patient stopped maintenance treatment, while the rest continued for one year.
Drug: golidocitinib
golidocitinib maintenance treatment given orally as 150mg every other day
Placebo Comparator: Arm B - Placebo Comparator: Placebo
Participants receive matching placebo capsules orally every other day in 28-day cycles for up to 24 months, or until disease progression, unacceptable toxicity, start of new anti-lymphoma therapy, withdrawal of consent, or study termination.
Device: PET-CTandct- DNAdetection
The patients who achieved CMR by PET-CT and MRD-neg by ct-DNA testing were evaluated at 12 months,One patient stopped maintenance treatment, while the rest continued for one year.
Drug: Placebo
Placebo given orally as 150mg every other day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: From randomization to the first documentation of disease progression, relapse, or death from any cause, up to approximately 3 years.
PFS is defined as the time from randomization to the first documented disease progression or relapse according to Lugano 2014 criteria, or death from any cause, whichever occurs first, as assessed by investigators. A blinded independent central review (BICR) will perform a sensitivity analysis of PFS to assess robustness.
From randomization to the first documentation of disease progression, relapse, or death from any cause, up to approximately 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death from any cause, up to approximately 5 years.
Time from randomization to death from any cause.
From randomization until death from any cause, up to approximately 5 years.
Complete Response Rate (CRR)
Time Frame: From randomization to end of treatment, up to 24 months.
Proportion of patients achieving complete response (CR) according to Lugano 2014 criteria.
From randomization to end of treatment, up to 24 months.
Duration of Response (DOR)
Time Frame: From the first documented response (CR or PR) to disease progression, relapse, or death, up to approximately 3 years.
Duration of response among patients who achieve CR or PR.
From the first documented response (CR or PR) to disease progression, relapse, or death, up to approximately 3 years.
Time to Next Anti-lymphoma Therapy (TTNT)
Time Frame: From randomization to the start of the next systemic anti-lymphoma therapy or death, up to approximately 3 years.
ime from randomization to the first administration of subsequent anti-lymphoma therapy or death.
From randomization to the start of the next systemic anti-lymphoma therapy or death, up to approximately 3 years.
MRD Negativity Rate by ctDNA at 12 Months
Time Frame: 12 months after randomization.
Proportion of patients who achieve minimal residual disease (MRD)-negative status by ctDNA assessment at 12 months.
12 months after randomization.
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug to 28 days after the last dose.
Number and percentage of patients experiencing TEAEs, serious adverse events (SAEs), grade ≥3 AEs, AEs leading to dose interruption, dose reduction, or treatment discontinuation.
From first dose of study drug to 28 days after the last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Rong Tao, MD &PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-START-M1-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Maintenance Treatment of Peripheral T-cell Lymphoma

Clinical Trials on PET-CTandct- DNAdetection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe