NCT05182957 Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma
| NCT ID | NCT05182957 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Relapsed/Refractory Peripheral T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2023-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 31 participants in total. It began in 2020-01-01 with a primary completion date of 2023-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Depei Wu, M.D
STUDY CHAIR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT05182957 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed/Refractory Peripheral T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05182957 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05182957 currently recruiting?
Yes, NCT05182957 is actively recruiting participants. Contact the research team at licaixia@suda.edu.cn for enrollment information.
Where is the NCT05182957 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT05182957 clinical trial?
NCT05182957 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Depei Wu, M.D at The First Affiliated Hospital of Soochow University. The trial plans to enroll 31 participants.