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

NCT ID: NCT05182957

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2023-12-14

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 limited, the first-line therapy is usually CHOP-like therapy, but the efficacy is poor, 5-year overall survival rate (OS) is only 30%-40%. Anti-PD-1 monoclonal antibody, Lenalidomide and Azacitidine can all have tumor-killing effects, and the three have complementary theoretical basis in the mechanism of action. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine

Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine

Group Type: EXPERIMENTAL

Anti-PD-1 monoclonal antibody

Intervention Type: DRUG

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

Lenalidomide

Intervention Type: DRUG

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

Azacitidine

Intervention Type: DRUG

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

Interventions

Anti-PD-1 monoclonal antibody

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

Intervention Type: DRUG

Lenalidomide

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

Intervention Type: DRUG

Azacitidine

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

Intervention Type: DRUG

Other Intervention Names

Anti-PD-1 antibody; Immunomodulator; 5-Ladakamycin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Depei Wu, M.D

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Caixia Li, M.D

Role: CONTACT

licaixia@suda.edu.cn

+86 512 67781856

Facility Contacts

Caixia Li, M.D

Role: primary

licaixia@suda.edu.cn

+86 512 67781856

Other Identifiers

R/R PTCL 01

Identifier Type: -

Identifier Source: org_study_id