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In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.
In this open-label, randomized, prospective clinical trial, CBF AML(including AML1-ETO or CBF-MYH11 mutated patients) patients who have reached CR are randomised into two groups and receive HDAC or high dose of cytarabine plus chidamide.
In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day and chidamide at a dose of 20mg/d twice a week for 3 months.Patients in control group only receive cytarabine at the same dose.
The safety and efficacy of chidamide is evaluated. The primary outcome is relapse-free survival rate after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose of Cytarabine | Active Comparator | CBF Patients who reach CR after reduction therapy receive high dose of cytarabine. |
|
| HDAC + Chidamide | Experimental | CBF Patients who reach CR after reduction therapy receive high dose of cytarabine plus chidamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine | Drug | Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-Free Survival Rate (RFS) | RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for CBF positive leukemia patients who achieve CR. | Within 5 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Non-relapse Mortality | through treatment completion, an average of 5 months | |
| Overall Survival Rate (OS) | Within 5 years after randomization | |
| Cumulative incidence of relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, Dr | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Chidamide | Drug | Chidamide at a dose of 20mg/d twice a week for 3 months. |
|
| Within 5 years after randomization |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |