Myelodysplastic Syndrome
Conditions
Interventions
low-dose group of uroacitide :The dose of testing agents
middle dose group of uroacitide:The dose of testing agents
High dose group of uroacitide:The dose of testing agents
Sponsors
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Shanghai 6th People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. According to the diagnostic Vienna criteria of MDS , patients with subtype MDS of low risk and middle risk - 1 were grouped by IPSS international prognostic score; 2. the patient is between the ages of 18 and 85 (including 18 and 85 years old); 3. haven't used the drugs such as methylation , such as 5-azoside (5-aza) and dixiabine (DAC), etc.;Drugs that were not used in the latest three months ,such as methylation haven't used, such as 5-azoside (5-aza) and dixiabine (DAC), etc; 4. ECOG score of 0~2; 5. Cr =1.5ULN, BUN =1.5ULN, ALT= twice ULN, AST=twice ULN, Tbil=1.5 times ULN; 6. Ever used cell stimulating factor, at the beginning of the study stop cytokine therapy a month ago; 7. before dosing has the past medical history and treatment of accurate within 8 weeks (blood transfusion amount, hemoglobin measurement, etc.); 8. The patient or family members to understand and voluntarily signed informed consent.;Inclusion criteria: 1. According to the diagnostic Vienna criteria of MDS , patients with subtype MDS of low risk and middle risk - 1 were grouped by IPSS international prognostic score; 2. the patient is between the ages of 18 and 85 (including 18 and 85 years old); 3. haven't used the drugs such as methylation , such as 5-azoside (5-aza) and dixiabine (DAC), etc.;Drugs that were not used in the latest three months ,such as methylation haven't used, such as 5-azoside (5-aza) and dixiabine (DAC), etc; 4. ECOG score of 0~2; 5. Cr =1.5ULN, BUN =1.5ULN, ALT= twice ULN, AST=twice ULN, Tbil=1.5 times ULN; 6. Ever used cell stimulating factor, at the beginning of the study stop cytokine therapy a month ago; 7. before dosing has the past medical history and treatment of accurate within 8 weeks (blood transfusion amount, hemoglobin measurement, etc.); 8. The patient or family members to understand and voluntarily signed informed consent.;Inclusion criteria: 1. According to the diagnostic Vienna criteria of MDS , patients with subtype MDS of low risk and middle risk - 1 were grouped by IPSS international prognostic score; 2. the patient is between the ages of 18 and 85 (including 18 and 85 years old); 3. haven't used the drugs such as methylation , such as 5-azoside (5-aza) and dixiabine (DAC), etc.;Drugs that were not used in the latest three months ,such as methylation haven't used, such as 5-azoside (5-aza) and dixiabine (DAC), etc; 4. ECOG score of 0~2; 5. Cr =1.5ULN, BUN =1.5ULN, ALT= twice ULN, AST=twice ULN, Tbil=1.5 times ULN; 6. Ever used cell stimulating factor, at the beginning of the study stop cytokine therapy a month ago; 7. before dosing has the past medical history and treatment of accurate within 8 weeks (blood transfusion amount, hemoglobin measurement, etc.); 8. The patient or family members to understand and voluntarily signed informed consent.;Inclusion criteria: 1. According to the diagnostic Vienna criteria of MDS , patients with subtype MDS of low risk and middle risk - 1 were grouped by IPSS international prognostic score; 2. the patient is between the ages of 18 and 85 (including 18 and 85 years old); 3. haven't used the drugs such as methylation , such as 5-azoside (5-aza) and dixiabine (DAC), etc.;Drugs that were not used in the latest three months ,such as methylation haven't used, such as 5-azoside (5-aza) and dixiabine (DAC), etc; 4. ECOG score of 0~2; 5. Cr =1.5ULN, BUN =1.5ULN, ALT= twice ULN, AST=twice ULN, Tbil=1.5 times ULN; 6. Ever used cell stimulating factor, at the beginning of the study stop cytokine therapy a month ago; 7. before dosing has the past medical history and treatment of accurate within 8 weeks (blood transfusion amount, hemoglobin measurement, etc.); 8. The patient or family members to understand and voluntarily signed informed consent.;Inclusion criteria: 1. According to the diagnostic Vienna criteria of MDS , patients with subtype MDS of low risk and middle risk - 1 were grouped by IPSS international prognostic score; 2. the patient is between the ages of 18 and 85 (including 18 and 85 years old); 3. haven't used the drugs such as methylation , such as 5-azoside (5-aza) and dixiabine (DAC), etc.;Drugs that were not used in the latest three months ,such as methylation haven't used, such as 5-azoside (5-aza) and dixiabine (DAC), etc; 4. ECOG score of 0~2; 5. Cr =1.5ULN, BUN =1.5ULN, ALT= twice ULN, AST=twice ULN, Tbil=1.5 times ULN; 6. Ever used cell stimulating factor, at the beginning of the study stop cytokine therapy a month ago; 7. before dosing has the past medical history and treatment of accurate within 8 weeks (blood transfusion amount, hemoglobin measurement, etc.); 8. The patient or family members to understand and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. intermediate-2 or high risk MDS; 2. For the first dose in the study within 30 days before the treatment, had received a research-based drug therapy; 3. 5 q-syndrome; 4. A history of tumor and accept the treatment of the tumor in the past three years, But remove the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, Cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN); 5. Have active viral or bacterial infections, and failed to properly in anti-infection treatment; 6. Serum erythropoietin (EPO) levels less than 200 mu/ml; 7. People with mental disorders or other condition and cannot cooperate for research treatment and monitoring requirements; 8. Pregnancy (women with reproductive age should undergo pregnancy screening) and nursing patients; 9. Diagnosed with HIV, active hepatitis and serological reaction is positive; 10. The researchers believe that the candidates should not be chosen.;Exclusion criteria: 1. intermediate-2 or high risk MDS; 2. For the first dose in the study within 30 days before the treatment, had received a research-based drug therapy; 3. 5 q-syndrome; 4. A history of tumor and accept the treatment of the tumor in the past three years, But remove the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, Cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN); 5. Have active viral or bacterial infections, and failed to properly in anti-infection treatment; 6. Serum erythropoietin (EPO) levels less than 200 mu/ml; 7. People with mental disorders or other condition and cannot cooperate for research treatment and monitoring requirements; 8. Pregnancy (women with reproductive age should undergo pregnancy screening) and nursing patients; 9. Diagnosed with HIV, active hepatitis and serological reaction is positive; 10. The researchers believe that the candidates should not be chosen.;Exclusion criteria: 1. intermediate-2 or high risk MDS; 2. For the first dose in the study within 30 days before the treatment, had received a research-based drug therapy; 3. 5 q-syndrome; 4. A history of tumor and accept the treatment of the tumor in the past three years, But remove the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, Cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN); 5. Have active viral or bacterial infections, and failed to properly in anti-infection treatment; 6. Serum erythropoietin (EPO) levels less than 200 mu/ml; 7. People with mental disorders or other condition and cannot cooperate for research treatment and monitoring requirements; 8. Pregnancy (women with reproductive age should undergo pregnancy screening) and nursing patients; 9. Diagnosed with HIV, active hepatitis and serological reaction is positive; 10. The researchers believe that the candidates should not be chosen.;Exclusion criteria: 1. intermediate-2 or high risk MDS; 2. For the first dose in the study within 30 days before the treatment, had received a research-based drug therapy; 3. 5 q-syndrome; 4. A history of tumor and accept the treatment of the tumor in the past three years, But remove the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, Cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN); 5. Have active viral or bacterial infections, and failed to properly in anti-infection treatment; 6. Serum erythropoietin (EPO) levels less than 200 mu/ml; 7. People with mental disorders or other condition and cannot cooperate for research treatment and monitoring requirements; 8. Pregnancy (women with reproductive age should undergo pregnancy screening) and nursing patients; 9. Diagnosed with HIV, active hepatitis and serological reaction is positive; 10. The researchers believe that the candidates should not be chosen.;Exclusion criteria: 1. intermediate-2 or high risk MDS; 2. For the first dose in the study within 30 days before the treatment, had received a research-based drug therapy; 3. 5 q-syndrome; 4. A history of tumor and accept the treatment of the tumor in the past three years, But remove the base layer of superficial bladder cancer, skin cell or squamous cell carcinoma, Cervical intraepithelial cancerous (CIN) or prostate intraepithelial (PIN); 5. Have active viral or bacterial infections, and failed to properly in anti-infection treatment; 6. Serum erythropoietin (EPO) levels less than 200 mu/ml; 7. People with mental disorders or other condition and cannot cooperate for research treatment and monitoring requirements; 8. Pregnancy (women with reproductive age should undergo pregnancy screening) and nursing patients; 9. Diagnosed with HIV, active hepatitis and serological reaction is positive; 10. The researchers believe that the candidates should not be chosen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of hematology improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood transfusion requirements change;observe complete remission (CR) and partial response (PR);Hematology improve (HI) maintain time;The quality of life (QLQ); | — |
Countries
China
Contacts
Public ContactZhijian Xiao;Zhijian Xiao;Zhijian Xiao;Zhijian Xiao;Zhijian Xiao ;;;;
Blood Diseases Hospital, Chinese Academy of Medical Sciences;Blood Diseases Hospital, Chinese Academy of Medical Sciences;Blood Diseases Hospital, Chinese Academy of Medical Sciences;Blood Diseases Hospital, Chinese Academy of Medical Sciences;Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed