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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2011 by Xiao Li, Shanghai 6th People's Hospital.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Xiao Li, Shanghai 6th People's Hospital

ClinicalTrials.gov Identifier:

NCT01417767

First received: August 15, 2011

Last updated: September 8, 2016

Last verified: September 2011

History of Changes

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 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:

MedlinePlus related topics: Myelodysplastic Syndromes

Drug Information available for: Decitabine

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Xiao Li, Shanghai 6th People's Hospital:

Primary Outcome Measures:

complete remission rate [ Time Frame: four weeks after one course of CHG or two courses of Decitabine ]

Secondary Outcome Measures:

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 ]


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 (Child, Adult, Senior)
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.

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


Responsible Party:	Xiao Li, Doctor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier:	NCT01417767 History of Changes
Other Study ID Numbers:	CHG－DAC 001 SHDC12010202 ( Other Grant/Funding Number: Shanghai Shenkang Center for hospital development )
Study First Received:	August 15, 2011
Last Updated:	September 8, 2016

Keywords provided by Xiao Li, Shanghai 6th 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	Antineoplastic Agents 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 August 16, 2017

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