A multicenter clinical study for compound Huangdai tablet combined with Decitabine / CAG (HAG) regimen in the treatment of high risk MDS

Multicenter clinical study for integrated traditional Chinese and Western medicine in the treatment of high risk MDS

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002791

Enrollment

Unknown

Registered

2019-11-30

Start date

2019-12-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

MDS

Interventions

Control group:Decitabine / CAG (HAG)

Experimental group:compound Huangdai tablet combined with Decitabine / CAG (HAG)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) informed consent was obtained from the patient or his family; 2) according to WHO classification, IPSS-R prognosis was confirmed in high-risk MDS patients; 3) aged between 18 to 75 years; 4) Physical Strength Score (ECOG score 0-3; 5) liver and renal function: Bilirubin 50%; 7) predicted survival >=3 months.

Exclusion criteria

Exclusion criteria: 1) ECOG score>4; 2) serum Bilirubin > 2 Mgdl 35 Mol/L; ALT or AST > 2 x Upper limit of normal; Alkaline phosphatase > 3 ULN; Serum Creatinine > 177 Mol/L; 3) HIV test positive; 4) other serious diseases that may limit patients from participating in the trial (e.g. progressive infection, uncontrolled diabetes, severe cardiac insufficiency or Angina); 5) pregnant or lactating women or persons with General Conditions Not Suitable for chemotherapy; 6) who do not understand or follow the protocol.

Design outcomes

Primary

Measure	Time frame
OS;EFS;CR;	—

Countries

China

Contacts

Public ContactLin Shengyun

lsyww2003@163.com+86 13588887285

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026