Brief Title
Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia
Official Title
Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia : An Open-Label, Single-Arm, Phase 2 Study.
Brief Summary
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall response rate
Secondary Outcome
Progress-free survival (PFS)
Condition
Acute Myeloid Leukemia
Intervention
Camrelizumab(SHR-1210)
Study Arms / Comparison Groups
Camrelizumab(SHR-1210) Combined With Decitabine
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
April 25, 2020
Completion Date
December 31, 2022
Primary Completion Date
December 31, 2020
Eligibility Criteria
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:
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).
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.
Gender
All
Ages
60 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Junmin Li, +86-13818659448, [email protected]
Administrative Informations
NCT ID
NCT04353479
Organization ID
MA-AML-II-001
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Jiao Tong University School of Medicine
Study Sponsor
Junmin Li, Principal Investigator, Ruijin Hospital
Verification Date
April 2020