Nodal Follicular Helper T-Cell Lymphoma
Conditions
Interventions
Experimental group:Limpliser and azacitidine combined with Doenda for treatment
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed nodal T-follicular helper (TFH) cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry (including subtypes: angioimmunoblastic T-cell lymphoma, follicular variant of nodal TFH cell lymphoma, and nodal TFH cell lymphoma, NOS); 2.Age >=18 years; 3.Eastern Cooperative Oncology Group (ECOG) performance status score 1.5 cm and the longest perpendicular diameter [LPD] >=1.0 cm, assessed by computed tomography [CT] or magnetic resonance imaging [MRI]; a maximum of 6 target lesions may be selected); 5.Adequate organ function meeting the following criteria: Hematologic parameters: Hemoglobin (HB) >=70 g/L, platelets (PLT) >=50 × 10^9/L, absolute neutrophil count (NE) >=1.0 × 10^9/L (Note: Patients must not have received blood transfusions or hematopoietic growth factors within 1 week prior to screening. Patients with cytopenia due to lymphoma bone marrow involvement are exempt from this criterion). Cardiac function:Left ventricular ejection fraction (LVEF) >=50% by echocardiography. Renal function:Serum creatinine =60 mL/min. Hepatic function:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 months; 8.Willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Major surgery or significant trauma within 2 weeks prior to enrollment, or unresolved major adverse effects from such procedures; 2.Current or prior malignancy within the past 3 years, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial neoplasia, or carcinoma in situ of the cervix; 3.History of stroke or intracranial hemorrhage within the past 3 months; 4.Any concurrent condition or medical disorder that may interfere with study conduct or place the patient at significant risk, including but not limited to: Severe cardiovascular disease (e.g., New York Heart Association [NYHA] Class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina). Severe pulmonary disease(e.g., severe chronic obstructive pulmonary disease or history of symptomatic bronchospasm). 5.Human immunodeficiency virus (HIV) infection, or uncontrolled active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection; 6.Uncontrolled active infection requiring systemic therapy; 7.Women who are pregnant or breastfeeding; 8.Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s judgment, could compromise patient safety; 9.Any condition that may interfere with the absorption or metabolism of linperlisib, azacitidine, or duvelisib, or that may pose unnecessary risks to the interpretation of study results; 10.Central nervous system (CNS) involvement by lymphoma; 11.Any condition that, in the investigator’s opinion, may interfere with the patient’s full participation in the study, pose significant risks to the patient, or confound the interpretation of study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CRR); | — |
Countries
China
Contacts
Public ContactCaixia Li
The First Affiliated Hospital of Soochow University
Outcome results
None listed