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| Name | Class |
|---|---|
| Chipscreen Biosciences, Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chidamide and azacitidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chidamide and azacitidine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of RFS in 6 months | relapse-free survival | 6 months |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WENG jian yu, M.D. | Contact | 020-83827812 | wengjianyu1969@163.com | |
| Ling Wei, M.D. | Contact | 020-83827812 | nick97@163.com |
| Name | Affiliation | Role |
|---|---|---|
| WENG jian yu, M.D. | Department of Hematology, Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| 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 |
minimal residual disease
| 24 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |