Anti‑PD‑1 with lenalidomide and azacitidine for 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

This study will test whether adding an anti‑PD‑1 antibody to lenalidomide and azacitidine helps adults with relapsed or refractory peripheral T‑cell lymphoma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05182957 on ClinicalTrials.gov

What this trial studies

This single‑center Phase 2 interventional study gives a combination of an anti‑PD‑1 monoclonal antibody together with lenalidomide and azacitidine to adults with relapsed or refractory peripheral T‑cell lymphoma. Eligible participants must have measurable disease after prior therapies, be at least 18 years old, have ECOG performance status ≤2, and meet specified organ function requirements. Participants will receive the combination regimen and be followed for tumor response and safety outcomes. The trial is conducted at The First Affiliated Hospital of Soochow University in Suzhou, Jiangsu.

Who should consider this trial

Good fit: Adults (≥18 years) with relapsed or refractory peripheral T‑cell lymphoma who have measurable lesions, ECOG ≤2, adequate organ function, and prior lines of therapy consistent with the protocol are the intended participants.

Not a fit: Patients with poor organ function, uncontrolled infections, pregnant or breastfeeding individuals, or those without measurable disease are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, the combination could increase response rates and offer a new treatment option for patients with relapsed or refractory PTCL.

How similar studies have performed: Anti‑PD‑1 agents, lenalidomide, and azacitidine have each shown activity in various lymphoid malignancies in prior studies, but this specific three‑drug combination for relapsed/refractory PTCL is novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

1. 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%.
2. Age ≥ 18 years.
3. ECOG≤2分.
4. 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%.
5. 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.
6. Estimated survival time ≥3 months.
7. Voluntary signing of informed consent.

Exclusion Criteria:

1. Accepted major surgery within 4 weeks before treatment.
2. 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;
3. Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.
4. Have stroke or intracranial hemorrhage within 3 months.
5. 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.
6. HIV infection and/or active hepatitis B or active hepatitis C.
7. Uncontrolled systemic infection.
8. Pregnant or breasting-feeding women.
9. 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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Caixia Li, M.D

Conditions: Relapsed/Refractory Peripheral T-cell Lymphoma, Anti-PD-1 monoclonal antibody,Lenalidomide,Azacitidine