Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to explore the efficacy and safety of azacytidine and HAG regimen versus azacytidine for elderly patients with Newly Diagnosed MDS/AML/CMML in China. This is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacytidine + HAG Regimen | Experimental | Azacytidine(75mg/m2 )+ HAG Regimen(Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) ) |
|
| Azacytidine | Active Comparator | 75mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacytidine, HAG Regimen | Drug | Azacytidine(75mg/m2 QD for 7 days)+ HAG Regimen(Homoharringtonine(HHT) 1mg/(m2.d) for 14 days), Cytarabine 10mg/(m2.d) for 14 days, granulocyte colony-stimulating factor(G-CSF) 200ug/(m2.d) for 14 days until absolute neutrophil count(ANC) ≥ 10X109/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments. | 4 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | 518035 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Azacytidine | Drug | Azacytidine 75mg/m2 QD for 7 days. |
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided