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

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.

Study Overview

• Status: Recruiting
• Conditions: Minimal Residual Disease; AML, Adult
• Intervention / Treatment: Drug: chidamide and azacitidine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WENG jian yu, M.D.; Phone Number: 020-83827812; Email: wengjianyu1969@163.com
• Study Contact Backup: Name: Ling Wei, M.D.; Phone Number: 020-83827812; Email: nick97@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: WENG jian yu, M.D.; Phone Number: （020）83827812; Email: wsswjy@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chidamide and azacitidine	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of RFS in 6 months	relapse-free survival	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of MRD turn negative in 6 months	minimal residual disease turn negative	6 months
the time length of MRD negative	minimal residual disease negative	24 months
the 1 year/2 year RFS	relapse-free survival	24 months
the 1 year/2 year OS	overall survival	24 months
the rate of GVHD	graft-versus-host disease	24 months
Incidence of Treatment-Emergent Adverse Events	Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
T cell receptor excision circles (TRECs) level before and after treatment	T cell receptor excision circles (TRECs) are released upon rearrangement of the T cell receptor.	24 months
the rate of MRD turn negative in molecular genetic abnormality subtype	minimal residual disease	24 months

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Shenzhen Chipscreen Biosciences Co.Ltd
• Investigators: Principal Investigator: WENG jian yu, M.D., Department of Hematology, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 26, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm, Residual; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Azacitidine
• Other Study ID Numbers: Chidaza101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No