NCT04353479

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 25, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

April 14, 2020

Last Update Submit

April 16, 2020

Conditions

Acute Myeloid Leukemia

Keywords

PD1 inhibitorDNA methyltransferase inhibitorAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Progress-free survival (PFS)

    2 years

  • Overall survival (OS)

    2 years

  • 6-month overall survival rate

    6 months

  • 12-month overall survival rate

    12 months

  • Hematological and non-hematological toxicity

    2 years

Study Arms (1)

Camrelizumab(SHR-1210) Combined With Decitabine

EXPERIMENTAL

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)Drug: Decitabine

Interventions

Camrelizumab(SHR-1210)DRUG

A humanized monoclonal immunoglobulin

Also known as: PD1 inhibitor
Camrelizumab(SHR-1210) Combined With Decitabine
DecitabineDRUG

A DNA methyltransferase inhibitor

Also known as: 5-aza-2- deoxycytidine
Camrelizumab(SHR-1210) Combined With Decitabine

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Treatment-related AML
  • Allergic to Camrelizumab, Decitabine, other monoclonal antibody or pharmaceutical excipients
  • Use of immunosuppressive drug within 2 weeks before entering the group
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

camrelizumabImmune Checkpoint InhibitorsDecitabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic UsesAzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Junmin Li

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Xue

CONTACT

+86-13818659448xuekaishanghai@126.com

Hongming Zhu

CONTACT

daphnezhming@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Hematology

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 20, 2020

Study Start

April 25, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share