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Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT

ConditionLeukemia, Myeloid, Acute
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSichuan University

About this trial

The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.

Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);

KPS score > 60 or ECOG score 0-2;

The expected survival period > 3 months;

Received allo-HSCT and achieved complete remission (CR);

Disqualifiers

Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;

Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;

Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;

Poor graft function (PGF) occurred after allo-HSCT;

Trial design

Design model

Single group

Treatments tested in this trial

  • Chidamide

    Drug

    initial time：platelet count ≥50×10\^9/L after allo-HSCT initial dose: 5 mg oral twice weekly initial adjustment: according to the platelet count tested weekly platelet count ≥50×10\^9/L-increased by 5 mg 20×10\^9/L≤ platelet count \<50×10\^9/L-remains unchanged platelet count \<50×10\^9/L- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal time: 180 days after allo-HSCT

Treatment groups

77 Participants
are divided into 1 treatment group
Group A: ChidamideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Progression free survival of this group of patients at the end of 2 year

Time frame
2 years

Secondary outcomes

1

100 day adverse events (AE)

non-hematologic adverse events

Time frame
Day +100
2

Non-relapse mortality (NRM)

Non-relapse mortality of this group of patients at the end of 6 month

Time frame
6 months
3

Overall survival (OS)

Overall survival of this group of patients at the end of 2 year

Time frame
2 years
4

Relapse rate

Relapse rate of this group of patients at the end of 2 year

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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