Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia

Study Overview
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Brief Summary
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This is an open-label, single arm, phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with DNA methyltransferase inhibitor decitabine in elderly patients with relapse and refractory acute myeloid leukemia.

Detailed Description
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In this single-center, open-label, nonrandomized, no control, prospective clinical trial, 29 relapsed or refractory acute myeloid leukemia patients will be enrolled. Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.

Official Title
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Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia : An Open-Label, Single-Arm, Phase 2 Study.

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Camrelizumab(SHR-1210)
* Drug: Decitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 60-75 Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology ECOG：0-2 Life expectancy ≥ 3 months Adequate laboratory parameters during the screening period as evidenced by the following: Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L ALT and AST ≤ 3 × upper limit of normal (ULN) FEV1,FVC,DLCO ≥ 50% predicted value Left ventricular ejection fraction (LVEF) ≥ 40%, no symptomatic arrhythmia Able to understand and sign an informed consent form (ICF). Exclusion Criteria: Treatment-related AML Allergic to Camrelizumab, Decitabine, other monoclonal antibody or pharmaceutical excipients Use of immunosuppressive drug within 2 weeks before entering the group Abnormal liver and kidney function(does not meet the inclusion criteria) Suffering from heart failure Active tuberculosis or HIV positive Active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common. Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted Concurrent medical condition requiring the long-term use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10 mg/day topical prednisone or equivalent Suffer from other hematological neoplasm Known history of use other immune checkpoint inhibitor Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camrelizumab(SHR-1210) Combined With Decitabine<br>Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity. | Drug: Camrelizumab(SHR-1210)<br>* A humanized monoclonal immunoglobulin<br>* Other names: PD1 inhibitor;Drug: Decitabine<br>* A DNA methyltransferase inhibitor<br>* Other names: 5-aza-2- deoxycytidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | CR, CRi, and morphologic leukemia-free state (MLFS) | 6 months | 
| Complete remission (CR) rate | Blast and promyelocytic leukemia less than 5% in bone marrow | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival (PFS) | PFS is defined from the date of entry on study until disease progression, including treatment failure, relapse from CR, or death from any causes. | 2 years | 
| Overall survival (OS) | OS is defined for patients entering the study as time to death of all causes. | 2 years | 
| 6-month overall survival rate | To evaluate overall survival rate at 6 months from study entry. | 6 months | 
| 12-month overall survival rate | To evaluate overall survival rate at 12 months from study entry. | 12 months | 
| Hematological and non-hematological toxicity | Assessed according to the Common Terminology Criteria for Adverse Events Version 4.03. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD1 inhibitor, DNA methyltransferase inhibitor, Acute Myeloid Leukemia