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| Name | Class |
|---|---|
| Xian-Janssen Pharmaceutical Ltd. | INDUSTRY |
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The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.
The outcome of the elderly AML patients is very poor. No obvious progress was achieved in this field. Decitabine is a kind of specific DNA methylation shift enzyme inhibitor. It can reverse the DNA methylation and induce the differentiation and apoptosis of the tumor cells. Recent studies about decitabine in the treatment for elderly AML patients had achieved inspiring results and indicated that low dose decitabine maybe a good choice for elderly AML patients. So in this research the investigators plan to evaluate the safety and the therapeutic effect of decitabine in the treatment of elderly AML patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine, CR rate,OS,EFS,RFS | Other | Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug |
The 1st cycle: 20 mg/m2, (iv,>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle. If bone marrow blast cells<5%, the following cycle:decitabine 20 mg/m2, (iv,>1h) on d1-5 of each 28 day cycle. If Grade 4 neutropenia(<0.5×10E9/L)come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia(<0.5×10E9/L)come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,>1h, on d1-3 of each 28day cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate after induction chemotherapy with decitabine | 21 days after the induction chemotherapy | |
| Overall survival rate | Up to 46 months after inclusion | |
| Event free survival rate | Up to 46 months after inclusion | |
| Relapse free survival rate | Up to 46 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of decitabine for elderly AML patients | Up to 46 months | |
| Weight of elderly AML patients | Up to 46 months | |
| ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, MD | Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17315155 | Background | Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007 Mar 15;109(6):1114-24. doi: 10.1002/cncr.22496. |
| Label | URL |
|---|---|
| We do not have a protocol's home page. This website is our hospital's home page and introduces some information of our hospital. | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 6, 2016 | |
| Reset | Nov 29, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 6, 2016 | Nov 29, 2016 |
| 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 |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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|
|
| Up to 46 months |
| Physical examination of decitabine for elderly AML patients | Up to 46 months |
| Blood pressure of elderly AML patients | Up to 46 months |
| Respiratory rate of elderly AML patients | Up to 46 months |
| Heart rate of elderly AML patients | Up to 46 months |
| Body temperature of elderly AML patients | Up to 46 months |
| ECG of elderly AML patients | Up to 46 months |
| Bone marrow condition of elderly AML patients | Up to 46 months |
| 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 |