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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Shanghai Sixth People's Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Xiao Li, Shanghai Sixth People's Hospital
ClinicalTrials.gov Identifier:
NCT01417767
First received: August 15, 2011
Last updated: September 1, 2011
Last verified: September 2011

August 15, 2011
September 1, 2011
September 2011
September 2013   (final data collection date for primary outcome measure)
complete remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01417767 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
  • overall remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ] [ Designated as safety issue: No ]
  • disease free survival [ Time Frame: two years ] [ Designated as safety issue: No ]
  • hematology toxicities [ Time Frame: within the first 4 weeks after CHG or Decitabine regimen ] [ Designated as safety issue: Yes ]
  • non-hematologic toxicities [ Time Frame: within the first 4 weeks after CHG or Decitabine ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

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).

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndromes
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
16 Years to 80 Years
No
Contact: Xiao Li, Doctor 008621-64369181-58745 lixiao3326@yahoo.com.cn
Contact: Lingyun Wu, Doctor 008621-64369181-58336 wu_lingyun@126.com
China
 
NCT01417767
CHG-DAC 001, SHDC12010202
No
Xiao Li, Shanghai Sixth People's Hospital
Xiao Li
Not Provided
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
Shanghai Sixth People's Hospital
September 2011

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