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Not yet recruitingNCT07753642Updated Aug 7, 2026

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

A Phase 2 interventional study of Golidocitinib and Doxorubicin in Nodal T-follicular Helper Cell Lymphoma, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Nodal T-follicular Helper Cell Lymphoma
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key inclusion Criteria:

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

Key exclusion Criteria:

  1. Hemophagocytic syndrome.
  2. Central nervous system or meningeal involvement by lymphoma.
  3. Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.
  4. Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.
  5. Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.
  6. Patients with severe or uncontrolled cardiovascular disease.
  7. Patients with a history of interstitial lung disease, except for asymptomatic radiation-induced interstitial lung disease.
  8. Patients with gastrointestinal conditions that may interfere with oral administration or drug absorption.
  9. Patients with known hypersensitivity to golidocitinib or its excipients.
  10. Pregnant or breastfeeding women and participants of childbearing potential unwilling to use effective contraception.
  11. Patients who have received systemic corticosteroids or other immunosuppressive therapy within 14 days before the start of study treatment.
  12. Patients considered unsuitable for participation by the investigator.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    Golidocitinib Combined with Doxorubicin/Epirubicin

    Participants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg/m² intravenously on Day 1 or epirubicin 60-90 mg/m² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator.

    Drug: Golidocitinib · Drug: Doxorubicin · Drug: Epirubicin

Interventions

  • DrugGolidocitinib

    150mg, po, qd

  • DrugDoxorubicin

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

  • DrugEpirubicin

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

05

What researchers measure

Primary outcomes

  1. Complete response rate

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

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

Secondary outcomes

  1. Progression-free survival(PFS)

    To investigate the preliminary anti-tumor efficacy.

    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.

  2. Overall survival(OS)

    To investigate the preliminary anti-tumor efficacy

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

  3. Objective response rate (ORR)

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

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

  4. Duration of Response(DOR)

    To investigate the preliminary anti-tumor efficacy

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

  5. Adverse events

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

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

06

Study locations

1 site
  • Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
    Guangzhou, Guangdong 51000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07753642
Lead sponsor
Sun Yat-sen University
Responsible party
Qingqing Cai (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Aug 7, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 30, 2029 (estimated)
Last update
Aug 7, 2026

Study contacts

Qingqing Cai, MD. PhD.
Contact
caiqq@sysucc.org.cn
02087342823

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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