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

Myelodysplastic Syndromes Clinical Trial

Official title:

Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01417767
• Other study ID #: CHG-DAC 001
• Secondary ID: SHDC12010202
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: August 15, 2011
• Last updated: September 8, 2016
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2011
• Source: Shanghai 6th People's Hospital
• Contact: Xiao Li, Doctor
• Phone: 008621-64369181-58745
• Email: lixiao3326[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai 6th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xiao Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate		four weeks after one course of CHG or two courses of Decitabine	No
Secondary	overall survival		two years	No
Secondary	overall remission rate		four weeks after one course of CHG or two courses of Decitabine	No
Secondary	disease free survival		two years	No
Secondary	hematology toxicities		within the first 4 weeks after CHG or Decitabine regimen	Yes
Secondary	non-hematologic toxicities		within the first 4 weeks after CHG or Decitabine	Yes