Relapsed/Refractory Peripheral T-cell Lymphoma
Conditions
Keywords
Anti-PD-1 monoclonal antibody,Lenalidomide,Azacitidine
Brief summary
Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
Detailed description
Peripheral T-cell lymphomas (PTCLs) are malignancies of immunologically mature T-cells that arise in peripheral lymphoid tissues. Compared with B-cell lymphoma, the treatment methods of PTCL are more limited, the first-line therapy is usually CHOP-like therapy, but the efficacy is poor, 5-year overall survival rate (OS) is only 30%-40%. Anti-PD-1 monoclonal antibody, Lenalidomide and Azacitidine can all have tumor-killing effects, and the three have complementary theoretical basis in the mechanism of action. This study will evaluate the efficacy and safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma patients.
Interventions
DRUGAnti-PD-1 monoclonal antibody
Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d)
DRUGLenalidomide
Lenalidomide 25mg qd po d1-d10 (/21d)
DRUGAzacitidine
Azacitidine 75mg/m2 i.v d1-d7 (/21d)
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathological immunohistochemistry or flow cytometry confirmed that R/R PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1\> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by \<50%; 2\> PTCL with disease progression after first-line or induction therapy; 3\> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%. 2. Age ≥ 18 years. 3. ECOG≤2分. 4. The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70\*1012/L，PLT≥50\*109/L，NE≥1\*109/L；LVEF≥50%;CR≤132umol/l or CCr≥60 ml/min;ALT and AST≤2 times normal range；Lung function≤Level 1;dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption\> 91%. 5. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study. 6. Estimated survival time ≥3 months. 7. Voluntary signing of informed consent.
Exclusion criteria
1. Accepted major surgery within 4 weeks before treatment. 2. Prior malignancy (other than Relapsed/Refractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer,malignant tonsilloma or carcinoma in situ; 3. Patients who have previously received failed allogeneic hematopoietic stem cell transplantation. 4. Have stroke or intracranial hemorrhage within 3 months. 5. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease. 6. HIV infection and/or active hepatitis B or active hepatitis C. 7. Uncontrolled systemic infection. 8. Pregnant or breasting-feeding women. 9. According to the researchers' judgment, any life-threatening disease, medical condition or organ system dysfunction which can endanger the patient's safety and Interfer with the absorption or metabolism of anti-PD-1 monoclonal antibody plus Lenalidomide and Azacitidine,may put the results of a study at unnecessary risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) at 6 cycles | From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks. | The percentage of participants achieving a best overall response of confirmed Complete Response (CR) or Partial Response (PR) after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate at 6 cycles | From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks. | The percentage of patients who achieved complete response after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine |
| 3-year progression-free survival (PFS) rate | up to 3 years | 3-year PFS rate is defined as the percentage of participants who are alive and free from disease progression at 3 years from the first dose of treatment. Participants who are alive and progression-free or lost to follow-up before 3 years will be censored at the date of last adequate tumor assessment. |
| 3-year Overall Survival(OS) Rate | up to 3 years | 3-year OS rate is defined as the percentage of participants who are alive at 3 years from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine. Participants who are alive or lost to follow-up before 3 years will be censored at the date of last known follow-up. |
| Adverse events profile | Measured from start of treatment until 28 days after last dose | Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated |
Countries
China
Contacts
CONTACTCaixia Li, M.D
STUDY_CHAIRDepei Wu, M.D
The First Affiliated Hospital of Soochow University
Outcome results
None listed