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To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide combined with venetoclax, azacitidine group | Experimental | Chidamide (C): 30 mg/d orally on d1, 4, 8, 11 or 10 mg QD, d1-d14, adjusted according to patient tolerance Azacitidine (A): 75 mg/m 2 /d subcutaneous injection d1-d7 Venetoclax (V): 100 mg d1 200 mg d 2 400 mg d3-d28 Orally A treatment cycle is 28 days , and subjects will continue to receive treatment allocation according to the investigator's assessment until documented disease progression, intolerable toxicity, withdrawal of consent, or the subject meets other conditions for terminating treatment. Program Standards (whichever occurs first). |
|
| venetoclax, azacitidine group | Active Comparator | azacitidine: 75 mg/m 2 /d subcutaneous injection d1-d7 Venetoclax: 100 mg day 1, 200 mg day 2, 400 mg day 3-d28 orally A treatment cycle is 28 days , and subjects will continue to receive treatment allocation according to the investigator's assessment until documented disease progression, intolerable toxicity, withdrawal of consent, or the subject meets other conditions for terminating treatment. Program Standards (whichever occurs first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | 30 mg/d orally twice-weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite complete remission rate | Composite complete remission rate after 2 cycles of treatment [Complete remission, CR) + complete remission with incomplete blood count (CR with incomplete blood count recovery, CRi); CR + CRi ] | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Overall response rate (ORR), including complete remission (Complete remission (CR), complete remission with incomplete blood count (CR with incomplete blood count recovery (CRi), morphological leukemia free state (MLFS), and partial remission (PR) as a percentage of the total number of patients participating in the efficacy analysis. | 24months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxiang Wang, Medical PhD | Contact | 022-23909273 | wangjx@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, MD | Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| 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 |
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Venetoclax |
| Drug |
100 mg d1 200 mg d 2 400 mg d3-d28 Orally |
|
| azacitidine | Drug | 75 mg/m 2 /d subcutaneous injection or IV d1-d7 |
|
| Overall survival (OS) | Overall survival (OS): defined as the number of days from the date of randomization to the date of death. Subjects who have not died will be censored on the last date they are known to be alive . | 24months |
| MRD response rate | Minimal residual disease (MRD)rate: defined as less than 0.1% remaining blasts per white blood cell, as measured by bone marrow examination. Other thresholds can also be explored and correlated with efficacy results. Subjects who are randomized but not assessed for MRD will be considered MRD response rate non-responders. The proportion of subjects achieving an MRD response (CR + CRi) was calculated. | 24months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |