Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
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| ClinicalTrials.gov Identifier: NCT01417767 |
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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
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Sponsor:
Xiao Li
Information provided by (Responsible Party):
Xiao Li, Shanghai 6th People's Hospital
| Tracking Information | ||||||||||
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| 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 |
complete remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ] | |||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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 |
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| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Myelodysplastic Syndromes | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Unknown status | |||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 ) |
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| 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 |
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| PRS Account | Shanghai 6th People's Hospital | |||||||||
| Verification Date | September 2011 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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