Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
This study is not yet open for participant recruitment.
Verified September 2011 by Shanghai Sixth People's Hospital
Sponsor:
Xiao Li
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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Drug: CHG regimen Drug: 5-aza-deoxycytidine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS |
Resource links provided by NLM:
Further study details as provided by Shanghai Sixth People's Hospital:
Primary Outcome Measures:
- complete remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CHG regimen
one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)
|
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)
|
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
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417767
Contacts
| Contact: Xiao Li, Doctor | 008621-64369181-58745 | lixiao3326@yahoo.com.cn |
| Contact: Lingyun Wu, Doctor | 008621-64369181-58336 | wu_lingyun@126.com |
Locations
| China, Shanghai | |
| Shanghai 6th People's Hospital | Not yet recruiting |
| Shanghai, Shanghai, China, 200233 | |
| Contact: Xiao Li lixiao3326@yahoo.com.cn | |
| Principal Investigator: Xiao Li | |
Sponsors and Collaborators
Xiao Li
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Xiao Li, Doctor, Shanghai Sixth People's Hospital |
| ClinicalTrials.gov Identifier: | NCT01417767 History of Changes |
| Other Study ID Numbers: | CHG－DAC 001, SHDC12010202 |
| Study First Received: | August 15, 2011 |
| Last Updated: | September 1, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shanghai Sixth People's Hospital:
|
myelodysplastic syndromes Decitabine homoharringtonine cytarabine G-CSF |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Cytarabine Decitabine Azacitidine Homoharringtonine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013