Trial | NCT01417767  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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).
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.
Study Started
Sep 30
2011
Primary Completion
Sep 30
2013
Anticipated
Study Completion
Sep 30
2013
Anticipated
Last Update
Sep 09
2016
Estimate

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 names: Low dose chemotherapy

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 names: Dacogen

CHG regimen Experimental

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

Decitabine Active Comparator

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

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.
No Results Posted