Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Golidocitinib, Doxorubicin, Epirubicin.
- Who it may be relevant to
- Registry conditions: Nodal T-follicular Helper Cell Lymphoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Golidocitinib
150mg, po, qd - Drug Doxorubicin
50 mg/m² intravenously on Day 1 of each 21-day cycle - Drug Epirubicin
60-90 mg/m² intravenously on Day 1 of each 21-day cycle
Primary outcome measures
- Complete response rate [Time frame: Up to 6 cycles (each cycle is 21 days)]
Secondary outcome measures (5)
- 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.]
- Overall survival(OS) [Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months]
- Objective response rate (ORR) [Time frame: Up to 6 cycles (each cycle is 21 days)]
- 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]
- Adverse events [Time frame: Up to 28 days after the last dose of study treatment]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT07753642 · B2026-455