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

Leukemia, Myeloid, Acute Clinical Trial

Official title:

Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I/II Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682755
• Other study ID #: PTChi 1.0
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 22, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2022
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years old and = 65 years old when signing the Informed Consent Form (ICF);

2. KPS score > 60 or ECOG score 0-2;

3. The expected survival period > 3 months;

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

5. Reach the standard of hematopoietic reconstitution (neutrophil count = 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count = 20×10^9/L for 7 consecutive days without platelet transfusion, Hb = 80 g /L without red blood cell transfusion); and neutrophil count = 1.5×10^9/L, platelet count = 50×10^9/L within 45 days after transplantation;

6. No central nervous system involvement or clinical symptoms after transplantation;

7. Those who have no serious functional damage to important organs of the body;

8. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;

9. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.

Exclusion Criteria:

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

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

3. 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;

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

5. Combined with other malignant tumors and require treatment;

6. Active GVHD;

7. Have a history of allergy to Chidamide;

8. Pregnant or lactating females;

9. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;

10. Patients with active chronic hepatitis B or active hepatitis C;

11. History of prolonged QT syndrome;

12. Patients considered by other researchers to be unsuitable for this study.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrence

Intervention

Drug:
• Chidamide
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

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Progression free survival of this group of patients at the end of 2 year	2 years
Secondary	100 day adverse events (AE)	non-hematologic adverse events	Day +100
Secondary	Non-relapse mortality (NRM)	Non-relapse mortality of this group of patients at the end of 6 month	6 months
Secondary	Overall survival (OS)	Overall survival of this group of patients at the end of 2 year	2 years
Secondary	Relapse rate	Relapse rate of this group of patients at the end of 2 year	2 years
Secondary	Cumulative incidence of acute graft versus host disease (aGVHD)	Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100	Day +100
Secondary	Cumulative incidence of chronic graft versus host disease (cGVHD)	Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year	2 years