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

NCT ID: NCT01417767

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

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).

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.

Conditions

Myelodysplastic Syndromes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHG regimen

one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)

Group Type: EXPERIMENTAL

CHG regimen

Intervention Type: DRUG

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.

Decitabine

one course of Decitabine (5-aza-deoxycytidine,Dacogen)

Group Type: ACTIVE_COMPARATOR

5-aza-deoxycytidine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Low dose chemotherapy; Dacogen

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiao Li

OTHER

Sponsor Role: lead

Responsible Party

Xiao Li

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiao Li, Doctor

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Lingyun Wu, Doctor

Role: STUDY_DIRECTOR

Shanghai 6th People's Hospital

Chunkang Chang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Locations

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Xiao Li, Doctor

Role: CONTACT

lixiao3326@yahoo.com.cn

008621-64369181-58745

Lingyun Wu, Doctor

Role: CONTACT

wu_lingyun@126.com

008621-64369181-58336

Facility Contacts

Xiao Li

Role: primary

lixiao3326@yahoo.com.cn

Other Identifiers

SHDC12010202

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CHG-DAC 001

Identifier Type: -

Identifier Source: org_study_id