MDS/AML
Conditions
Interventions
Research Group:Azacytidine maintenance therapy
Sponsors
Huadong Hospital Affiliate to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. After blood count, bone marrow examination and cytogenetic examination, diagnosed as any of the following diseases: subjects with AML (M0-M2 and M4-M7, FAB classification); refractory anemia with blast cells Excessive (RAEB) or refractory anemia with excess blasts during transformation (RAEB-t), IPSS score >=1.5; MDS (primary or secondary, FAB classification), and International Prognostic Scoring System ( IPSS) score >= 1; 3. The laboratory test results of liver and kidney function meet the following criteria: aspartate aminotransferase (AST): =50 mL/min (using the Cockcroft-Gault formula); proteinuria =2+, 24-hour urine protein must be <2 g ); 4. ECOG PS score: 0-2 points; 5. Achieve complete remission after first-line induction therapy; 6. The increase in bone marrow blast cells is less than 5% and there is no Auer body, including patients with MRD (+) or (-); 7. Female subjects must be postmenopausal, or surgically sterilized, or abstinent. If sexually active, effective contraception must be used (eg, prescription oral contraceptives, injectable contraceptives, IUDs, double-blocking, contraceptive patches, male partner sterilization) prior to study entry and throughout the study period ; Serum or urine pregnancy test results must be negative at screening and throughout the study period; 8. Male subjects should take effective contraceptive measures within 6 months after receiving or completing treatment; 9. The subjects volunteered to be tested and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have participated in other clinical trials within 30 days; 2. Breastfeeding patients; 3. Active viral or bacterial infection that cannot be controlled with appropriate anti-infective therapy; 4. Known positive for HIV, hepatitis B virus or active hepatitis C virus serology; 5. Suffering from mental disorders or other conditions and cannot cooperate with the requirements of research treatment and monitoring; 6. Bone marrow emptying; 7. Those who are known to be allergic to any component of the program; 8. Past resistance to azacitidine; 9. Known severe congestive heart failure; 10. Chronic obstructive pulmonary disease with severe restrictive ventilation dysfunction; 11. Concurrent serious and/or uncontrolled other medical conditions (such as uncontrolled diabetes, hypertension, solid tumors, etc.); 12. The investigator determines that the patient is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal residual disease; | — |
Countries
China
Contacts
Public ContactXie Yanhui
Huadong Hospital Affiliated to Fudan University
Outcome results
None listed