Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

Phase

2/3

Condition

White Cell Disorders

Myelodysplastic Syndromes (Mds)

Treatment

N/A

Clinical Study ID

NCT01417767

CHG－DAC 001

SHDC12010202

Ages 16-80
All Genders

Study 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).

Eligibility Criteria

Inclusion

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 metabolicdiseases;
adequate hepatic (serum bilirubin level <2×upper normal limit) and renal (serumcreatinine <2×upper normal limit) function tests.

Exclusion

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.

Study Design

September 01, 2011

September 30, 2013

Study 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.

Connect with a study center

Shanghai 6th People's Hospital
Shanghai, Shanghai 200233
China
Site Not Available

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