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

Phase 2

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: CHG regimen; Drug: 5-aza-deoxycytidine

• Registration Number: NCT01417767
• Lead Sponsor: Xiao Li

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.

Study Timeline

• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Status Verified: 2011-09
• Study Start: 2011-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHG regimen	CHG regimen	one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)
Decitabine	5-aza-deoxycytidine	one course of Decitabine (5-aza-deoxycytidine,Dacogen)

Primary Outcome Measures

Name	Time	Method
complete remission rate	four weeks after one course of CHG or two courses of Decitabine

Secondary Outcome Measures

Name	Time	Method
non-hematologic toxicities	within the first 4 weeks after CHG or Decitabine
overall survival	two years
overall remission rate	four weeks after one course of CHG or two courses of Decitabine
disease free survival	two years
hematology toxicities	within the first 4 weeks after CHG or Decitabine regimen

Trial Locations

Locations (1)

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, Shanghai, China