Status:
UNKNOWN
Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Relapsed/Refractory Peripheral T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
Peripheral T-cell lymphomas (PTCLs) are malignancies of immunologically mature T-cells that arise in peripheral lymphoid tissues. Compared with B-cell lymphoma, the treatment methods of PTCL are more ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05182957
Start Date
December 14 2022
End Date
December 14 2023
Last Update
January 31 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000