A Study of Chidamide With AZA in MRD Positive AML After Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2026-12-31

Brief Summary

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acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.

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Detailed Description

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Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.

Conditions

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AML, Adult Minimal Residual Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chidamide and azacitidine

Group Type EXPERIMENTAL

chidamide and azacitidine

Intervention Type DRUG

chidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally.

azacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally.

Interventions

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chidamide and azacitidine

chidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally.

azacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT);
2. ≥18 years old;
3. ECOG≤3;
4. lifespan≥3 months;
5. Take contraceptive measures;
6. Sign informed consent.

Exclusion Criteria

1. Allergic to the study drug;
2. A gastrointestinal condition that prevents oral medication;
3. active infection;
4. Dysfunction of vital organs;
5. other malignancies;
6. HIV infection;
7. HBV or HCV;
8. The QT interval is prolonged;
9. Pregnant or lactating women;
10. Is participating in other clinical studies;
11. The researchers did not consider it appropriate to participate in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No