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

Acute Myeloid Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04353479
• Other study ID #: MA-AML-II-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 25, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Kai Xue
• Phone: +86-13818659448
• Email: xuekaishanghai[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 29
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Camrelizumab(SHR-1210)
A humanized monoclonal immunoglobulin
• Decitabine
A DNA methyltransferase inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	CR, CRi, and morphologic leukemia-free state (MLFS)	6 months
Primary	Complete remission (CR) rate	Blast and promyelocytic leukemia less than 5% in bone marrow	6 months
Secondary	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
Secondary	Overall survival (OS)	OS is defined for patients entering the study as time to death of all causes.	2 years
Secondary	6-month overall survival rate	To evaluate overall survival rate at 6 months from study entry.	6 months
Secondary	12-month overall survival rate	To evaluate overall survival rate at 12 months from study entry.	12 months
Secondary	Hematological and non-hematological toxicity	Assessed according to the Common Terminology Criteria for Adverse Events Version 4.03.	2 years