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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes
Decitabine
Azacitidine
Homoharringtonine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014