peripheral T-cell lymphoma
Conditions
Interventions
Test group:Dovelisib + Azacitidine + Tirilizumab
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients or their legal guardians voluntarily participated and signed an informed consent form; 2. Male or female patients aged 18 to 70 years (inclusive of 18 and 70 years); 3. PTCL diagnosed by pathohistology and/or cytology, with the following subtypes: peripheral T-cell lymphoma, nonspecific (PTCL, NOS); peripheral T-cell lymphoma (PTCL) with a follicular helper T-cell (TFH) phenotype including angioimmunoblastic T-cell lymphoma (AITL), TFH lymphoma, and intranodal peripheral T-cell lymphomas with TFH phenotype; ALK+ systemic interstitial large T-cell lymphoma (ALCL, ALK+); ALK- systemic interstitial large T-cell lymphoma (ALCL, ALK-); 4. Meet the criteria for relapsed/refractory lymphoma: relapsed lymphoma is defined as lymphoma that has relapsed after achieving a complete remission (CR) with initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following: 1) tumor shrinkage 1.5 cm in length; for non-lymph node lesions, measurable extranodal lesions need to be >1.0 cm in length; 6. Patients with good function of major tissues and organs: liver function: ALT/AST =50%; 7. Patient ECOG score =3 months; 9. Bone marrow function: neutrophil count >=1.5×10^9/L, platelet count >=75×10^9/L, hemoglobin >=80g/L (patients with bone marrow involvement can be relaxed to neutrophil count >=1.0×10^9/L, platelet count >=50×10^9/L, hemoglobin >=75g/L); 10. Women of childbearing age must have had a pregnancy test (serum or urine) with negative results within 14 days prior to enrollment and be willing to use a reliable method of contraception for the duration of the trial.
Exclusion criteria
Exclusion criteria: 1. Extranodal NK/T-cell lymphoma; 2. Known or existing primary or metastatic CNS lymphoma; 3. Subject's prior history of antitumor therapy meets one of the following criteria: a.Prior receipt of dovelisib or other PI3K inhibitors; b.Those who have previously received PD-1 or PD-L1 inhibitors; c.Persons with AITL previously treated with azacitidine; d. Received antitumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking herbal medicines with antitumor activity, etc.) or participated in other clinical trials and received clinical trial medication within 4 weeks or 5 half-lives, whichever comes first, prior to the first use of study drug; e.Received autologous hematopoietic stem cell transplantation within 6 months; f. Having received an allogeneic hematopoietic stem cell transplant in the past. 4. Severe organ failure or myocardial infarction within the last 6 months; 5. Men or women who are planning to conceive within the last 1 year. 6. Patients with uncontrolled infections within 4 weeks prior to enrollment; 7. Active hepatitis B or C infection; 8. Patients with HIV infection; 9. Patients with severe autoimmune or immunodeficiency diseases; 10. Patients with a known history of immediate or delayed hypersensitivity reactions to the study drug and similar drugs; 11. Patients with systemic hormone use within 4 weeks prior to enrollment (except for patients using inhaled hormones); 12. Suffering from a psychiatric disorder; 13. Patients with substance abuse/addiction; 14. Patients are not guaranteed to use effective contraception (condoms or contraceptive pills, etc.) for 1 year after enrollment; 15. Patients with other conditions that, in the judgment of the investigator, make them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Time To Response;Best Overall Response; | — |
Countries
China
Contacts
Public ContactMiao Zheng
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed