Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in 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

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: Anti-PD-1 monoclonal antibody; Drug: Lenalidomide; Drug: Azacitidine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine; Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine	Drug: Anti-PD-1 monoclonal antibody; Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d); Other Names: Anti-PD-1 antibody; Drug: Lenalidomide; Lenalidomide 25mg qd po d1-d10 (/21d); Other Names: Immunomodulator; Drug: Azacitidine; Azacitidine 75mg/m2 i.v d1-d7 (/21d); Other Names: 5-Ladakamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival(PFS)	To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months	up to 12 months
Overall Response Rate (ORR)	To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events profile	Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated	Measured from start of treatment until 28 days after last dose
Complete Response Rate	Number of patients who achieved complete response after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine	up to 12 months
Duration of Response	Duration of overall response will be assessed from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine given to progression,death or last follow-up.	up to 12 months
Overall Survival	OS will be assessed from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine given to death or last follow-up.	up to 12 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2022
• Primary Completion (ANTICIPATED): December 14, 2023
• Study Completion (ANTICIPATED): December 14, 2023

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (ACTUAL): January 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Anti-PD-1 monoclonal antibody,Lenalidomide,Azacitidine
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antibodies; Lenalidomide; Immunoglobulins; Azacitidine; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: R/R PTCL 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No