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Acute Myeloid LeukemiaPhase 2NCT04353479

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

A Phase 2 study testing Camrelizumab(SHR-1210) and Decitabine in people with Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Camrelizumab(SHR-1210) and Decitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
No sites listed yet
Study dates
25 Apr 2020to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

No sites are listed yet.

Kai Xue contact

+86-13818659448

xuekaishanghai@126.com

Hongming Zhu contact

daphnezhming@163.com

About this study

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.

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.

Read the 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.

Being tested
Camrelizumab(SHR-1210), Decitabine
Keywords
PD1 inhibitor, DNA methyltransferase inhibitor, Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab(SHR-1210)Drug

    Also called PD1 inhibitor

    A humanized monoclonal immunoglobulin

  • DecitabineDrug

    Also called 5-aza-2- deoxycytidine

    A DNA methyltransferase inhibitor

Study groups in NCT04353479
Study groupRoleWhat they receive
Camrelizumab(SHR-1210) Combined With DecitabineExperimentalPatients 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.
Receives: Drug: Camrelizumab(SHR-1210); Drug: Decitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

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

    Measured: 6 months

  2. Complete remission (CR) rate

    Blast and promyelocytic leukemia less than 5% in bone marrow

    Measured: 6 months

Secondary outcomes (5)

  1. 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.

    Measured: 2 years

  2. Overall survival (OS)

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

    Measured: 2 years

  3. 6-month overall survival rate

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

    Measured: 6 months

  4. 12-month overall survival rate

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

    Measured: 12 months

  5. Hematological and non-hematological toxicity

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start25 Apr 2020 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353479
Sponsor's protocol ID
MA-AML-II-001
Status last verified
Apr 2020
First submitted
14 Apr 2020
Last updated
20 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab(SHR-1210) and Decitabine in people with Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kai Xue (+86-13818659448, xuekaishanghai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.

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