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Exploratory study for the efficacy and safety of azacitidine in patients with medium-to-high risk myelodysplastic syndrome without hematologic improvement with desitabine

Exploratory study for the efficacy and safety of azacitidine in patients with medium-to-high risk myelodysplastic syndrome without hematologic improvement with desitabine

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026513
Enrollment
Unknown
Registered
2019-10-13
Start date
2019-10-28
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

MDS

Interventions

Case series:The use of azacitidine dose of 75 mg/m2, once a day, 7 days, every 28 days for a cycle

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) MDS defined by WHO2016 (see appendix 2); 2) aged >18 years old; 3) ipss-r rating medium, high risk and very high risk MDS (see appendix 3); 4) any HI that did not meet IWG2006 standards or developed disease progression for 4 cycles with the 20mg/m2/ dx5-day regimen of desitabine and/or was subsequently treated with only the best supportive therapy, allowing dose adjustments according to the instructions; 5) ECOG score 2 or less; 6) transplant or not; 7) women of childbearing age volunteered to use contraception and at least one effective contraceptive method during the study period; 8) male patients voluntarily avoided getting their partners pregnant and used at least one effective contraceptive method during the study period; 9) full liver and kidney functions: serum bilirubin <=1.5 times the upper normal value (ULN), AST<=2.0 ULN, ALT<=2.0 ULN, and serum creatinine <=1.5 ULN.

Exclusion criteria

Exclusion criteria: 1) patients who are known to be allergic to azarcytidine or mannitol; 2) previous use of azarcytidine for treatment; 3) malignancies diagnosed within the first 12 months of the study (except basal cell carcinoma, cervical or breast carcinoma in situ, and other tumors considered highly curable); 4) pregnant or lactating women; 5) patients with advanced malignant liver tumors; 6) other conditions deemed inappropriate for inclusion.

Design outcomes

Primary

MeasureTime frame
ny HI defined by IWG2006;

Countries

China

Contacts

Public ContactLiang Yang

Sun Yat-sen University Cancer Center

liangyang@sysucc.org.cn+86 13925136853

Outcome results

None listed

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