Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
16 Years
80 Years
Both
Myelodysplastic Syndromes
Trial Information
Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
complete remission rate
Outcome Time Frame:
four weeks after one course of CHG or two courses of Decitabine
Safety Issue:
No
Principal Investigator
Xiao Li, Doctor
Investigator Role:
Study Chair
Investigator Affiliation:
Shanghai 6th People's Hospital
Authority:
China: Food and Drug Administration
Study ID:
CHG－DAC 001
NCT ID:
NCT01417767
Start Date:
September 2011
Completion Date:
September 2013
Related Keywords:
- Myelodysplastic Syndromes
- myelodysplastic syndromes
- Decitabine
- homoharringtonine
- cytarabine
- G-CSF
- Myelodysplastic Syndromes
- Preleukemia
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