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| Name | Class |
|---|---|
| Second Affiliated Hospital of Soochow University | OTHER |
| Changzhou No.2 People's Hospital | OTHER |
| The First People's Hospital of Lianyungang | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients younger than 60 years.
This is a phase 3, randomized, controlled, multi-center study in newly diagnosed AML patients younger than 60. The patients will be randomized to receive either DAC combined with HAAG or IA regimen in the induction treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine combined with HAAG | Experimental | This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60. |
|
| IA Regimen | Active Comparator | This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine plus HAAG regimen | Drug | Decitabine:20mg/m2/d,d1~5, intravenous infusion; Homoharringtonine:1mg/d,d3~16,intravenous infusion; Aclarubicin:10mg/d, d3~d10, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-16, 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 |
|---|---|---|
| Overall Response Rate (ORR) | ORR includes complete response (CR), CRi and PR. 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; 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | time from randomization to death from any cause | 3 years |
| Leukemia-free survival (LFS) | time from randomization to the first relapse or death |
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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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | 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 |
|---|---|
| D000077209 | Decitabine |
| D015255 | Idarubicin |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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| Jingjiang People's Hospital |
| OTHER |
| Zhangjiagang First People's Hospital | OTHER |
| The Second People's Hospital of Huai'an | OTHER |
| The Third People's Hospital of Kunshan | UNKNOWN |
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|
| Idarubicine plus Cytarabine regimen | Drug | Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion |
|
| 3 years |
| Cumulative incidence of relapse(CIR) | time from achievement of a remmission to the first relapse | 3 years |
| Number of adverse events | adverse events are evaluated with CTCAE V5.0. | 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |