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

ConditionNodal T-follicular Helper Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

47 Participants
are divided into 1 treatment group
Group A: Golidocitinib Combined with Doxorubicin/EpirubicinExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: