To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation:A Multicenter, Single-arm Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

• 5.Patients with an ECOG performance status 0,1,2 or 3

• 6.Expected survival time ≥ 3 months

• 7.Non-hematological toxicity related to transplantation does not exceed Grade 2

• 8.Laboratory indicators meet the following standards:

‣ 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.

⁃ Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment.

⁃ Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion.

⁃ Serum creatinine clearance rate is greater than 30ml/min.

Locations
Other Locations
China
Nanfang Hospital of Southern Medical University
RECRUITING
Guanzhou
Contact Information
Primary
Rui Huang, Doctor
Rachelchn@163.com
+8615918528317
Backup
Yunqing Wang, Bachelor
Wangyun7q@163.com
+8618585509970
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Azacitidine combined with Chidamide
Patients will recieve six courses of azacitidine 50mg/m2 through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time patients will recieve oral chidamide 5mg per day for no more than 2 years.
Related Therapeutic Areas
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov

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