RecruitingPhase 2

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

China31 participantsStarted 2020-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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;

What they're measuring

Overall Response Rate (ORR) at 6 cycles

Timeframe: From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks.

Trial details

NCT IDNCT05182957

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-15

Contact for this trial

Caixia Li, M.D

+86 512 67781856 licaixia@suda.edu.cn

View on ClinicalTrials.gov More Relapsed/Refractory Peripheral T-cell Lymphoma trials