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RecruitingPhase 2NCT05182957

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

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

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

31 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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.

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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)

Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT05182957