Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZhujiang Hospital

About this trial

The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Age 18 to 60 years old,both male and female

2.Be able to understand and sign informed consent

3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic

4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML

Disqualifiers

1.Uncontrollable active infection

2.Patients with active hepatitis B or C or HIV infection before enrollment

3.Have a grade III-IV graft-versus-host disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Azacitidine

    Drug

    Patients will recieve six courses of azacitidine 50mg/m2 through a needle under skin on Days 1-3.Each course is 28 days long.

  • Chidamide

    Drug

    Patients will recieve oral chidamide 5mg per day for no more than 2 years.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Azacitidine combined with ChidamideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Paticipants With Adverse Events as a Measure of Safety

Safety were measured with respect to: 1. Safety measurements 2. Incidence of adverse events

Time frame
From the day of stem cell transplantation to one year after stem cell transplantation
2

One year cumulative incidence of relapse

Leukemia relapse base on morphoogy criterion

Time frame
From the day of stem cell transplantation to one year after stem cell transplantation

Secondary outcomes

1

Relapes-free Survival(RFS)

The time that a participant survives without relapes of the disease

Time frame
From the day of stem cell transplantation to one year after stem cell transplantation
2

Overall survival(OS)

The time that a participant survives without death

Time frame
From the day of stem cell transplantation to one year after stem cell transplantation
3

The cumulative Incidence rate of GVHD

acute GVHD and chronic GVHD diagnosis based on MIH criterion

Time frame
From the day of stem cell transplantation to one year after stem cell transplantation

Other outcomes

1

Single-cell sequencing

Single-cell sequencing was used to explore the potential mechanism of AZA combined with sidarbenamide to prevent recurrence after transplantation in patients with AML

Time frame
Before the maintenance therapy and before the 7 cycles of maintenance

Sponsors and contacts

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