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

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05182957
Collaborator
(none)
40
1
1
12
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study on the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma
Actual Study Start Date :
Dec 14, 2021
Anticipated Primary Completion Date :
Dec 14, 2022
Anticipated Study Completion Date :
Dec 14, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival(PFS) [up to 12 months]

      To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months

    2. Overall Response Rate (ORR) [up to 12 months]

      To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months

    Secondary Outcome Measures

    1. Complete Response Rate [up to 12 months]

      Number of patients who achieved complete response after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine

    2. Duration of Response [up to 12 months]

      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.

    3. Overall Survival [up to 12 months]

      OS will be assessed from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine given to death or last follow-up.

    4. Adverse events profile [Measured from start of treatment until 28 days after last dose]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 ≥701012/L,PLT≥50109/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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215000

    Sponsors and Collaborators

    • The First Affiliated Hospital of Soochow University

    Investigators

    • Study Chair: Depei Wu, M.D, The First Affiliated Hospital of Soochow University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT05182957
    Other Study ID Numbers:
    • R/R PTCL 01
    First Posted:
    Jan 10, 2022
    Last Update Posted:
    Jan 10, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The First Affiliated Hospital of Soochow University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 10, 2022