Myelodysplastic syndrome with excess blasts and Acute myeloid leukemia with myelodysplasia-related changes
Conditions
Interventions
Group 1:Decitabine in combination with half dose of CAG regimen.
Group 2:CAG scheme
Sponsors
People's Hospital, Institute of hematology, Peking University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Within 30 days before enrollment, patients are diagnosed as MDS-EB (5 =marrow primordial cells =19%) or AML-MRC based on blood cell count, bone marrow examination and cytogenetic examination according to WHO (revised edition 2016) criteria; 2) Aged at least 18 years; 3) ECOG score is 0-2 points or Karnofsky score is = 60 points; 4) Normal liver and kidney function (serum bilirubin =1.5 *ULN, serum ALT and AST =2.5 *ULN, serum Cr =1.5 *ULN); 5) Women of childbearing age should receive pregnancy examination before treatment, and must take effective contraceptive measures during treatment; 6) The participants shall sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Having received decitabine, azacytidine, other leukemia chemotherapy regimen, cytotoxic drugs (except hydroxyurea), or hematopoietic stem cell transplantation; 2) Known to be allergic to decitabine, aclarubicin or cytarabine; 3) Bone marrow dry tap; 4) Having participated in other clinical trials within 30 days; 5) Patients during pregnancy and lactation; 6) Having a history of tumor and received any treatment for this tumor in the past 3 years. 7) With severe heart disease, including acute myocardial infarction within 6 months, or meeting the Class III or IV cardiac function of New York Heart Association; 8) Active virus or bacterial infection and failure to control infection with appropriate anti-infection treatment. 9) Known positive for HIV or serological examination of active hepatitis C virus. 10) Known hepatitis B virus carriers or hepatitis B virus DNA positive patients without any treatment; 11) Failure to meet the requirements of treatment and monitoring due to mental illness or other conditions; 12) Patients attending other clinical trials at the same time; 13) Other situations the researchers believe that they are not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy indicators: complete remission rate (CR).; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) overall response rate (ORR) (overall response OR=CR+PR);2) cytogenetic remission;3) molecular biology remission;4) OS (1 and 2 years);5) PFS (1 and 2 years); | — |
Countries
China
Contacts
Public ContactHao Jiang
Peking University People's Hospital
Outcome results
None listed