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NCT Number: NCT07753642

Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma

This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, 51000, China

Location contact

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

02087342823

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key inclusion Criteria:

  • Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma according to the 2022 WHO classification.
  • Previously untreated with systemic anti-lymphoma therapy.
  • Age ≥18 and <75 years.
  • At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
  • An expected survival time of more than 12 weeks.
  • An ECOG performance status score of 0-1.
  • Adequate organ and bone marrow function.
  • Provision of written informed consent and willingness to comply with all study procedures.

Key exclusion Criteria:

  • Hemophagocytic syndrome.
  • Central nervous system or meningeal involvement by lymphoma.
  • Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.
  • Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.
  • Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.
  • Patients with severe or uncontrolled cardiovascular disease.
  • Patients with a history of interstitial lung disease, except for asymptomatic radiation-induced interstitial lung disease.
  • Patients with gastrointestinal conditions that may interfere with oral administration or drug absorption.
  • Patients with known hypersensitivity to golidocitinib or its excipients.
  • Pregnant or breastfeeding women and participants of childbearing potential unwilling to use effective contraception.
  • Patients who have received systemic corticosteroids or other immunosuppressive therapy within 14 days before the start of study treatment.
  • Patients considered unsuitable for participation by the investigator.

Treatment and study plan

golidocitinib

Drug

150mg, po, qd

Doxorubicin

Drug

50 mg/m² intravenously on Day 1 of each 21-day cycle

Epirubicin

Drug

60-90 mg/m² intravenously on Day 1 of each 21-day cycle

Primary outcomes

  1. Complete response rate

    Time frame: Up to 6 cycles (each cycle is 21 days)

    Defined as the proportion of patients who achieve complete remission at the end of induction treatment.

Secondary outcomes

  1. Progression-free survival(PFS)

    Time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

    To investigate the preliminary anti-tumor efficacy.

  2. Overall survival(OS)

    Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months

    To investigate the preliminary anti-tumor efficacy

  3. Objective response rate (ORR)

    Time frame: Up to 6 cycles (each cycle is 21 days)

    The proportion of patients who achieve complete remission (CR) or partial remission (PR)

  4. Duration of Response(DOR)

    Time frame: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months

    To investigate the preliminary anti-tumor efficacy

  5. Adverse events

    Time frame: Up to 28 days after the last dose of study treatment

    The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

02087342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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