Hemophagocytic lymphohistiocytosis associated with untreated peripheral T-cell lymphoma
Conditions
Interventions
Intervention group:All patients received golidocitinib 150 mg orally once daily (PO qd) in combination with lymphoma chemotherapy regimens.
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age:18 years <= age <= 75 years. 2. Newly diagnosed, histopathologically confirmed peripheral T-cell lymphoma (PTCL), including the following subtypes: - Angioimmunoblastic T-cell lymphoma (AITL) - Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) - Extranodal NK/T-cell lymphoma, nasal type - Aggressive NK-cell leukemia - Anaplastic large cell lymphoma (ALCL) - Enteropathy-associated T-cell lymphoma (EATL) - Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) 3. Meet the diagnostic criteria for hemophagocytic lymphohistiocytosis (HLH) according to HLH-2004 . 4. Life expectancy =1 month (investigator-assessed). 5. Ability to understand and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous exposure to chemotherapy for lymphoma; 2. Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 3. Known history of primary immunodeficiency; 4. Known active tuberculosis; 5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. Known allergy to any component of the investigational drug; 7. Uncontrolled concurrent illnesses, including but not limited to:HIV infection (HIV antibody positive); Severe infections that are active or clinically poorly controlled; Symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias; Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg); Any arterial thromboembolic event within 6 months before enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; Any life-threatening bleeding event or Grade 3 or 4 gastrointestinal/variceal bleeding requiring transfusion, endoscopy, or surgical treatment within 3 months before enrollment; History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months before enrollment (thrombosis related to implanted venous ports or catheters, or superficial venous thrombosis is not considered severe thromboembolism); History of intestinal obstruction or conditions such as inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn’s disease, ulcerative colitis, or chronic diarrhea;Other acute or chronic illnesses, psychiatric disorders, or abnormal laboratory findings that may increase the risk associated with study participation or investigational drug administration, or interfere with the interpretation of study results, and, in the investigator’s judgment, make the patient ineligible for participation in this study; 8. Known human immunodeficiency virus (HIV) infection, or active hepatitis B (HBsAg positive, or HBsAg negative but HBcAb positive with detectable HBV DNA) or hepatitis C infection (positive polymerase chain reaction (PCR) results); 9. History of gastrointestinal perforation and/or fistula within 6 months before enrollment; 10. Known interstitial lung disease; 11. Clinically uncontrolled third-space effusions, such as pleural or peritoneal effusions that cannot be managed by drainage or other methods before enrollment; 12. Concurrent use of strong or moderate CYP3A inhibitors or inducers, or narrow therapeutic index BCRP or P-gp sensitive substrates, unless discontinued at least one week before the first dose of the investigational drug; 13. Patients requiring concurrent use of vitamin K antagonists, antiplatelet agents, or anticoagulants, unless discontinued at least one week before the first dose of the investigational drug; 14. History of other primary malignancies, except: Malignancies cured =5 years before enrollment with no known active disease and minimal risk of recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease recurrence; Adequately treated carcinoma in situ with no evidence of disease recurrence; 15. Pregnant or breastfeeding female patien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-month survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) in HLH;Complete response (CR) rate in HLH;ORR in lymphoma;CR rate in lymphoma;Overall survival; | — |
Countries
China
Contacts
Public ContactLei Fan
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed