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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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 criteria

Qualifiers

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%.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Anti-PD-1 monoclonal antibody
  • Lenalidomide
  • Azacitidine

Treatment groups

31 Participants
are divided into 1 treatment group