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

NCT05182957 | Recruiting Phase 2

• 1 other identifier: R/R PTCL 01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory Peripheral T-cell Lymphoma

Keywords

Anti-PD-1 monoclonal antibody,Lenalidomide,Azacitidine

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Complete Response Rate at 6 cycles

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

• 3-year progression-free survival (PFS) rate

  up to 3 years

• 3-year Overall Survival(OS) Rate

  up to 3 years

• Adverse events profile

  Measured from start of treatment until 28 days after last dose

Study Arms (1)

Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine

EXPERIMENTAL

Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine

Drug: Anti-PD-1 monoclonal antibody; Drug: Lenalidomide; Drug: Azacitidine

Interventions

Anti-PD-1 monoclonal antibody DRUG

Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d)

Also known as: Anti-PD-1 antibody

Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine

Lenalidomide DRUG

Lenalidomide 25mg qd po d1-d10 (/21d)

Also known as: Immunomodulator

Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine

Azacitidine DRUG

Azacitidine 75mg/m2 i.v d1-d7 (/21d)

Also known as: 5-Ladakamycin

Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

spartalizumab; Lenalidomide; Immunologic Factors; Azacitidine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Depei Wu, M.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Caixia Li, M.D

CONTACT

+86 512 67781856; licaixia@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 10, 2022
• Study Start: January 1, 2020
• Primary Completion: December 15, 2023
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CN (1)