A multicenter clinical study for compound Huangdai tablet combined with Decitabine / CAG (HAG) regimen in the treatment of high risk MDS
- Conditions
- MDS
- Registration Number
- ITMCTR1900002791
- Lead Sponsor
- The First affiliated Hospital of Zhejiang Chinese Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1) informed consent was obtained from the patient or his family;
2) according to WHO classification, IPSS-R prognosis was confirmed in high-risk MDS patients;
3) aged between 18 to 75 years;
4) Physical Strength Score (ECOG score 0-3;
5) liver and renal function: Bilirubin <=2 mg/dL 35 mol/L, AST/ALT less than 2 times the upper limit of the normal value, creatinine <=177 mol/l;
6) Cardiac function was acceptable: EF >50%;
7) predicted survival >=3 months.
1) ECOG score>4;
2) serum Bilirubin > 2 Mgdl 35 Mol/L; ALT or AST > 2 x Upper limit of normal; Alkaline phosphatase > 3 ULN; Serum Creatinine > 177 Mol/L;
3) HIV test positive;
4) other serious diseases that may limit patients from participating in the trial (e.g. progressive infection, uncontrolled diabetes, severe cardiac insufficiency or Angina);
5) pregnant or lactating women or persons with General Conditions Not Suitable for chemotherapy;
6) who do not understand or follow the protocol.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OS;EFS;CR;
- Secondary Outcome Measures
Name Time Method