Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma

Official title

Clinical Study on the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma

Overview

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

• Drug Anti-PD-1 monoclonal antibody
  Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d)
• Drug Lenalidomide
  Lenalidomide 25mg qd po d1-d10 (/21d)
• Drug Azacitidine
  Azacitidine 75mg/m2 i.v d1-d7 (/21d)

Primary outcome measures

• Overall Response Rate (ORR) at 6 cycles [Time frame: From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks.]

Secondary outcome measures (4)

• Complete Response Rate at 6 cycles [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 [Time frame: up to 3 years]
• 3-year Overall Survival(OS) Rate [Time frame: up to 3 years]
• Adverse events profile [Time frame: Measured from start of treatment until 28 days after last dose]

Eligibility criteria

Inclusion criteria

• 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%.
• Age ≥ 18 years.
• ECOG≤2分.
• 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%.
• 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.
• Estimated survival time ≥3 months.
• Voluntary signing of informed consent.

Exclusion criteria

• Accepted major surgery within 4 weeks before treatment.
• 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;
• Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.
• Have stroke or intracranial hemorrhage within 3 months.
• 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.
• HIV infection and/or active hepatitis B or active hepatitis C.
• Uncontrolled systemic infection.
• Pregnant or breasting-feeding women.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT05182957 · R/R PTCL 01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗