Clinical trial · Interventional
Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
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
NCT07753642CI-TRIAL-00121020not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nodal T-follicular Helper Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Golidocitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Golidocitinib Combined with Doxorubicin/Epirubicin
- description
- 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.
- interventionNames
- Drug: Golidocitinib
- Drug: Doxorubicin
- Drug: Epirubicin
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- Up to 6 cycles (each cycle is 21 days)
- description
- Defined as the proportion of patients who achieve complete remission at the end of induction treatment.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.