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

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ClinicalTrials.gov Identifier: NCT01417767
Recruitment Status : Unknown
Verified September 2011 by Xiao Li, Shanghai 6th People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2011
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Xiao Li, Shanghai 6th People's Hospital

Tracking Information
First Submitted Date  ICMJE August 15, 2011
First Posted Date  ICMJE August 16, 2011
Last Update Posted Date September 9, 2016
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
complete remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2011)
  • complete remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
Official Title  ICMJE Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndromes
Intervention  ICMJE
  • 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.
    Other Name: Low dose chemotherapy
  • 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.
    Other Name: Dacogen
Study Arms  ICMJE
  • Experimental: CHG regimen
    one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)
    Intervention: Drug: CHG regimen
  • Active Comparator: Decitabine
    one course of Decitabine (5-aza-deoxycytidine,Dacogen)
    Intervention: Drug: 5-aza-deoxycytidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01417767
Other Study ID Numbers  ICMJE CHG-DAC 001
SHDC12010202 ( Other Grant/Funding Number: Shanghai Shenkang Center for hospital development )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiao Li, Shanghai 6th People's Hospital
Study Sponsor  ICMJE Xiao Li
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xiao Li, Doctor Shanghai 6th People's Hospital
Study Director: Lingyun Wu, Doctor Shanghai 6th People's Hospital
Principal Investigator: Chunkang Chang, Doctor Shanghai 6th People's Hospital
PRS Account Shanghai 6th People's Hospital
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP