Clinical trial NCT01417767: Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
Official title: Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Myelodysplastic Syndromes
Keywords: myelodysplastic syndromes
Decitabine
homoharringtonine
cytarabine
G-CSF
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: complete remission rate
timeFrame: four weeks after one course of CHG or two courses of Decitabine
Secondary outcomes:
measure: overall survival
timeFrame: two years
measure: overall remission rate
timeFrame: four weeks after one course of CHG or two courses of Decitabine
measure: disease free survival
timeFrame: two years
measure: hematology toxicities
timeFrame: within the first 4 weeks after CHG or Decitabine regimen
measure: non-hematologic toxicities
timeFrame: within the first 4 weeks after CHG or Decitabine
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Xiao Li, Doctor
role: STUDY_CHAIR
affiliation: Shanghai 6th People's Hospital
name: Lingyun Wu, Doctor
role: STUDY_DIRECTOR
affiliation: Shanghai 6th People's Hospital
name: Chunkang Chang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: