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

Xiao Li

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Myelodysplastic Syndromes

Treatments: Drug: CHG regimen; Drug: 5-aza-deoxycytidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01417767

CHG-DAC 001

SHDC12010202 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

CHG regimen

Experimental group

Description:

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

Treatment:

Drug: CHG regimen

Decitabine

Active Comparator group

Description:

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

Treatment:

Drug: 5-aza-deoxycytidine