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The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.
This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VA combined with HAAG | Experimental | This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venetoclax, azacitidine and HAAG regimen | Drug | Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3~10, per os; Azacitidine:75mg/m2/d, d1~7, subcutaneous injection; Homoharringtonine:1mg/d, d4~10, intravenous infusion; Aclarubicin:10mg/d, d4~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection; |
| Measure | Description | Time Frame |
|---|---|---|
| Composite complete response rate (CRc; CR+CRi) | CRc includes complete response CR and CRi; CR was defined as < 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as<5% bone marrow blasts, either ANC<1×10^9/L or platelets<100×10^9/L, transfusion independence but with persistence of cytopenia. | Day 28-35 of induction course |
| Measure | Description | Time Frame |
|---|---|---|
| Partial remission (PR) | PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts. | Day 28-35 of induction course |
| Number of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Tang, Ph.D | Contact | (0086)51267780086 | xwtang1020@163.com | |
| Depei Wu, Ph.D | Contact | (0086)51267780086 | drwudepei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaowen Tang, Ph.D | The First Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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adverse events are evaluated with CTCAE V5.0.
| 2 years |
| Relapse-free survival (RFS) | time from clinical CRc (CR and CRi) to the first relapse or death | 3 years |
| Overall survival (OS) | time from the first day of treatment to death or lost to follow-up for any cause. | 3 years |
| ID | Term |
|---|---|
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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