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

Primary Purpose

Acute Myeloid Leukemia

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Camrelizumab(SHR-1210)

Decitabine

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring PD1 inhibitor, DNA methyltransferase inhibitor, Acute Myeloid Leukemia

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab(SHR-1210) Combined With Decitabine

Arm 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.

Outcomes

Primary Outcome Measures

Overall response rate

CR, CRi, and morphologic leukemia-free state (MLFS)

Complete remission (CR) rate

Blast and promyelocytic leukemia less than 5% in bone marrow

Secondary Outcome Measures

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.

Overall survival (OS)

OS is defined for patients entering the study as time to death of all causes.

6-month overall survival rate

To evaluate overall survival rate at 6 months from study entry.

12-month overall survival rate

To evaluate overall survival rate at 12 months from study entry.

Hematological and non-hematological toxicity

Assessed according to the Common Terminology Criteria for Adverse Events Version 4.03.

Full Information

NCT ID

NCT04353479

First Posted

April 14, 2020

Last Updated

April 16, 2020

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04353479

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 25, 2020 (Anticipated)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

PD1 inhibitor, DNA methyltransferase inhibitor, Acute Myeloid Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab(SHR-1210) Combined With Decitabine

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab(SHR-1210)

Other Intervention Name(s)

PD1 inhibitor

Intervention Description

A humanized monoclonal immunoglobulin

Intervention Type

Drug

Intervention Name(s)

Decitabine

Other Intervention Name(s)

5-aza-2- deoxycytidine

Intervention Description

A DNA methyltransferase inhibitor

Primary Outcome Measure Information:

Title

Overall response rate

Description

CR, CRi, and morphologic leukemia-free state (MLFS)

Time Frame

6 months

Title

Complete remission (CR) rate

Description

Blast and promyelocytic leukemia less than 5% in bone marrow

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Progress-free survival (PFS)

Description

PFS is defined from the date of entry on study until disease progression, including treatment failure, relapse from CR, or death from any causes.

Time Frame

2 years

Title

Overall survival (OS)

Description

OS is defined for patients entering the study as time to death of all causes.

Time Frame

2 years

Title

6-month overall survival rate

Description

To evaluate overall survival rate at 6 months from study entry.

Time Frame

6 months

Title

12-month overall survival rate

Description

To evaluate overall survival rate at 12 months from study entry.

Time Frame

12 months

Title

Hematological and non-hematological toxicity

Description

Assessed according to the Common Terminology Criteria for Adverse Events Version 4.03.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kai Xue

Phone

+86-13818659448

xuekaishanghai@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hongming Zhu

daphnezhming@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junmin Li

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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