Nodal T-follicular Helper Cell Lymphoma
Conditions
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.
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
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | Up to 6 cycles (each cycle is 21 days) | Defined as the proportion of patients who achieve complete remission at the end of induction treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | To investigate the preliminary anti-tumor efficacy. |
| Overall survival(OS) | From the date of enrollment until the date of death from ant cause, assessed up to 24 months | To investigate the preliminary anti-tumor efficacy |
| Objective response rate (ORR) | Up to 6 cycles (each cycle is 21 days) | The proportion of patients who achieve complete remission (CR) or partial remission (PR) |
| 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 | To investigate the preliminary anti-tumor efficacy |
| Adverse events | Up to 28 days after the last dose of study treatment | The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs) |
Countries
China
Contacts
CONTACTQingqing Cai, MD. PhD.
Outcome results
None listed