Myelodysplastic Syndromes
Conditions
Keywords
myelodysplastic syndromes, Decitabine, homoharringtonine, cytarabine, G-CSF
Brief summary
The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(MDS).
Detailed description
Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2 years as well as a high risk of their disease progressing to acute myeloid leukemia (AML). The only treatment with a curative potential is allogeneic stem cell transplantation. However, in the majority of patients, this treatment is not applicable, mainly due to the age of the recipients and comorbid conditions. Low-dose chemotherapy CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming)has been used to treat higher-risk MDS in China and achieve high response rate. Hypomethylating agents 5-aza-2'-deoxycytidine (decitabine) is nucleoside analogs that covalently bind to the DNA methyltransferases, irreversibly inhibiting their function, leading to the progressive loss of methylation and reversal of gene silencing. The purpose of this study is to compare the efficacy and safety of CHG regimen to Decitabine in higher-risk MDS.
Interventions
DRUGCHG regimen
cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion, G-CSF (300 μg/d) by subcutaneous injection from day 0 until neutrophil count recovery to 2.0× 109/L.
DRUG5-aza-deoxycytidine
Decitabine (5-aza-deoxycytidine)for injection, 20mg/m2/day, IV (in the vein) on days 1-5 of each 28 day cycle, Number of Cycles: 2.
Sponsors
Xiao Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age rang from 16 to 80 years; * diagnosis of higher-risk MDS (with≥ 5% blast in bone marrow); * a performance status of 0-3 according to the Eastern Cooperative Oncology Group (ECOG); * no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases; * adequate hepatic (serum bilirubin level \<2×upper normal limit) and renal (serum creatinine \<2×upper normal limit) function tests.
Exclusion criteria
* Female with pregnancy; * a performance of 4-5 according to ECOG score; * HIV positive; * uncontrolled severe fungal infection or tuberculosis; * with other progressive malignant diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate | four weeks after one course of CHG or two courses of Decitabine |
Secondary
| Measure | Time frame |
|---|---|
| non-hematologic toxicities | within the first 4 weeks after CHG or Decitabine |
| hematology toxicities | within the first 4 weeks after CHG or Decitabine regimen |
| overall survival | two years |
| overall remission rate | four weeks after one course of CHG or two courses of Decitabine |
| disease free survival | two years |
Countries
China
Contacts
Primary ContactXiao Li, Doctor
Backup ContactLingyun Wu, Doctor
Outcome results
None listed