Efficacy and Safety of CHG Regimen in Treatment of High-risk MDS and MDS-AML

Efficacy and Safety Study of CHG Regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) in the Treatment of High-risk Myelodysplastic Syndromes(MDS) and Acute myeloid Leukemia Transformed

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-11001501

Enrollment

Unknown

Registered

2011-08-29

Start date

2006-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-risk MDS and AML transformed from MDS

Interventions

1:cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion, G-CSF (300 ug/d) by subcutaneous injection from day 0 until neutrophil count recovery to 2.0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age rang from 16 to 80 years; 2) diagnosis of high-risk MDS (with>=5% blast in bone marrow) or AML transformed from MDS; 3) a performance status of 0-3 according to the Eastern Cooperative Oncology Group (ECOG); 4) no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases; 5)adequate hepatic (serum bilirubin level <2*upper normal limit) and renal (serum creatinine <2*upper normal limit) function tests.

Exclusion criteria

Exclusion criteria: 1) age 80 years; 2) Female with pregnancy; 3) a performance of 4-5 according to ECOG score; 4) HIV positive; 5) uncontrolled severe fungal infection or tuberculosis; 6) with other progressive malignant diseases.

Design outcomes

Primary

Measure	Time frame
Complete Remission;	—

Secondary

Measure	Time frame
Overall Response;Overall Survival;	—

Countries

China

Contacts

Public ContactXiao Li

lixiao3326@yahoo.com.cn+86 021 64369181-58745

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 10, 2026