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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: CHG regimen Drug: 5-aza-deoxycytidine Phase 2 Phase 3

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. complete remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: two years ]
  2. overall remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ]
  3. disease free survival [ Time Frame: two years ]
  4. hematology toxicities [ Time Frame: within the first 4 weeks after CHG or Decitabine regimen ]
  5. non-hematologic toxicities [ Time Frame: within the first 4 weeks after CHG or Decitabine ]


Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Xiao Li, Doctor 008621-64369181-58745 lixiao3326@yahoo.com.cn
Contact: Lingyun Wu, Doctor 008621-64369181-58336 wu_lingyun@126.com

Locations
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China, Shanghai
Shanghai 6th People's Hospital
Shanghai, Shanghai, China, 200233
Contact: Xiao Li       lixiao3326@yahoo.com.cn   
Principal Investigator: Xiao Li         
Sponsors and Collaborators
Xiao Li
Investigators
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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
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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
Keywords provided by Xiao Li, Shanghai 6th People's Hospital:
myelodysplastic syndromes
Decitabine
homoharringtonine
cytarabine
G-CSF
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors