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

Overview

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).

Full Title of Study: “Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2013

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

  • Drug: CHG 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.
  • Drug: 5-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.

Arms, Groups and Cohorts

  • Experimental: CHG regimen
    • one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)
  • Active Comparator: Decitabine
    • one course of Decitabine (5-aza-deoxycytidine,Dacogen)

Clinical Trial Outcome Measures

Primary Measures

  • complete remission rate
    • Time Frame: four weeks after one course of CHG or two courses of Decitabine

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xiao Li
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Xiao Li, Doctor – Shanghai 6th People’s Hospital
  • Overall Official(s)
    • Xiao Li, Doctor, Study Chair, Shanghai 6th People’s Hospital
    • Lingyun Wu, Doctor, Study Director, Shanghai 6th People’s Hospital
    • Chunkang Chang, Doctor, Principal Investigator, Shanghai 6th People’s Hospital
  • Overall Contact(s)
    • Xiao Li, Doctor, 008621-64369181-58745, lixiao3326@yahoo.com.cn

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.