Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine | Experimental | Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall 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. | From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks. |
| 3-year progression-free survival (PFS) rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caixia Li, M.D | Contact | +86 512 67781856 | licaixia@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Depei Wu, M.D | The First Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lenalidomide | Drug | Lenalidomide 25mg qd po d1-d10 (/21d) |
|
|
| Azacitidine | Drug | Azacitidine 75mg/m2 i.v d1-d7 (/21d) |
|
|
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. |
| 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. | 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 | Measured from start of treatment until 28 days after last dose |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D000077269 | Lenalidomide |
| D007155 | Immunologic Factors |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001372 | Aza Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided