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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myelodysplastic Syndromes | Drug: CHG regimen Drug: 5-aza-deoxycytidine | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | September 2013 |
Estimated Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: CHG regimen
one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)
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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 |
Active Comparator: Decitabine
one course of Decitabine (5-aza-deoxycytidine,Dacogen)
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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 |
- 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 ]

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Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417767
Contact: Xiao Li, Doctor | 008621-64369181-58745 | lixiao3326@yahoo.com.cn | |
Contact: Lingyun Wu, Doctor | 008621-64369181-58336 | wu_lingyun@126.com |
China, Shanghai | |
Shanghai 6th People's Hospital | |
Shanghai, Shanghai, China, 200233 | |
Contact: Xiao Li lixiao3326@yahoo.com.cn | |
Principal Investigator: Xiao Li |
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 |
Responsible Party: | Xiao Li, Doctor, Shanghai 6th People's Hospital |
ClinicalTrials.gov Identifier: | NCT01417767 |
Other Study ID Numbers: |
CHG-DAC 001 SHDC12010202 ( Other Grant/Funding Number: Shanghai Shenkang Center for hospital development ) |
First Posted: | August 16, 2011 Key Record Dates |
Last Update Posted: | September 9, 2016 |
Last Verified: | September 2011 |
myelodysplastic syndromes Decitabine homoharringtonine cytarabine G-CSF |
Preleukemia Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms |
Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |