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

NCT07753642 | Not Yet Recruiting Phase 2

• 1 other identifier: B2026-455
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nodal T-follicular Helper Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

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

  Up to 6 cycles (each cycle is 21 days)

Secondary Outcomes (5)

• Progression-free survival(PFS)

  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)

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

• Objective response rate (ORR)

  Up to 6 cycles (each cycle is 21 days)

• Duration of Response(DOR)

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

• Adverse events

  Up to 28 days after the last dose of study treatment

Study Arms (1)

Golidocitinib Combined with Doxorubicin/Epirubicin

EXPERIMENTAL

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

Golidocitinib DRUG

150mg, po, qd

Golidocitinib Combined with Doxorubicin/Epirubicin

Doxorubicin DRUG

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

Golidocitinib Combined with Doxorubicin/Epirubicin

Epirubicin DRUG

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

Golidocitinib Combined with Doxorubicin/Epirubicin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 51000, China

Location

MeSH Terms

Interventions

Doxorubicin; Epirubicin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

02087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 30, 2029
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)