A multicenter, prospective, double arm clinical study for ultra low-dose decitabine combined with compound preparation of As4S4 in patients with intermediate-high risk myelodysplastic syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17011619

Enrollment

Unknown

Registered

2017-06-10

Start date

2017-07-31

Completion date

Unknown

Last updated

2017-06-12

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

Conditions

myelody splastic syndromes or chronic myelomonocytic leukemia

Interventions

A:decitabine

B:decitabine combined with compound preparation of As4S4

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults more than 18 years of age; 2. Have a diagnosis of MDS-RAEB-1, RAEB-2 or CMML fitting any of the recognized WHO classifications; 3. Patients with intermediate-1, intermediate-2 or high risk of MDS by international score of IPSS; 4. Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2; 5. Well Well liver and kidney function; 6. The normal ejective fraction measured by echocardiogram, and QT interval<460ms;7.Patients understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Patient's liver and kidney function was abnormal beyond the inclusion criteria; 2. Serum bilirubin, transaminase and serum creatinine was 2 times higher than the normal criteria; 3. Patients have serious heart disease,and heart function>grade 2; 4. Has prior malignancy and received any treatment for this prior malignancy; 5. Hasinaspirable bone marrow; 6. Has known hepatitis B(surface antigen-positive) or active hepatitis C, positive serology for HIV; 7. People with mental disorders or other condition and cannot cooperate for research treatment and monitoring requirements; 8. Have active viral or bacterial infections, and failed to properly in anti-infection treatment; 9. Patients that received treatment with other drugs within 30 days prior to the first dose in the study; 10. Has known hypersensitivity to any of the excipients of the drug used in the study.

Design outcomes

Primary

Measure	Time frame
overall response rate;	—

Secondary

Measure	Time frame
complete response rate;complete response rate of bone marrow;partial response rate;hematologic improvement;	—

Countries

China

Contacts

Public ContactQing Leng

Central Hospital of Anshan City, The sixth clinical college of China Medical University

aslq456@sina.com+86 0142 5930550

Outcome results

None listed

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