Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia
NCT ID: NCT04353479
Last Updated: 2020-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
29 participants
INTERVENTIONAL
2020-04-25
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Camrelizumab(SHR-1210) Combined With Decitabine
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.
Camrelizumab(SHR-1210)
A humanized monoclonal immunoglobulin
Decitabine
A DNA methyltransferase inhibitor
Interventions
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Camrelizumab(SHR-1210)
A humanized monoclonal immunoglobulin
Decitabine
A DNA methyltransferase inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
2. ALT and AST ≤ 3 × upper limit of normal (ULN)
3. FEV1,FVC,DLCO ≥ 50% predicted value
4. Left ventricular ejection fraction (LVEF) ≥ 40%, no symptomatic arrhythmia
5. Able to understand and sign an informed consent form (ICF).
* 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.
Exclusion Criteria
* Allergic to Camrelizumab, Decitabine, other monoclonal antibody or pharmaceutical excipients
* Use of immunosuppressive drug within 2 weeks before entering the group
60 Years
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Junmin Li
Director of Department of Hematology
Principal Investigators
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Junmin Li
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Central Contacts
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Other Identifiers
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MA-AML-II-001
Identifier Type: -
Identifier Source: org_study_id
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