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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d)
Lenalidomide 25mg qd po d1-d10 (/21d)
Azacitidine 75mg/m2 i.v d1-d7 (/21d)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall Response Rate (ORR) at 6 cycles
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.
Time frame: From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks.
Complete Response Rate at 6 cycles
The percentage of patients who achieved complete response after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine
Time frame: From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks.
3-year progression-free survival (PFS) rate
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.
Time frame: up to 3 years
3-year Overall Survival(OS) Rate
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.
Time frame: up to 3 years
Adverse events profile
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
Time frame: Measured from start of treatment until 28 days after last dose
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