Clinical Study on the Treatment of Elderly Acute Myelocytic Leukemia and Myelodysplastic Syndrome with Azacytidine Combined PD-1 Monoclonal Antibody

Clinical Study on the Treatment of Elderly Acute Myelocytic Leukemia and Myelodysplastic Syndrome EB1/2 with Azacytidine Combined PD-1 Monoclonal Antibody

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034927

Enrollment

Unknown

Registered

2020-07-24

Start date

2020-08-01

Completion date

Unknown

Last updated

2020-11-24

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

Conditions

Acute Myelocytic Leukemia / Myelodysplastic Syndrome EB1/2

Interventions

trial group:Azacytidine combined PD-1 Monoclonal Antibody

control group:Azacytidine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged >= 65 years; 2. AML, include primary AML, secondary AML (including MDS/MPN conversion, treatment-related AML); 3. MDS-EB,include MDS-EB1 and MDS-EB2.

Exclusion criteria

Exclusion criteria: 1. Low-risk AML, include(15;17), t(8; 21), inv16 , etc. 2. Other serious conditions that may limit the patient's participation in the trial (e.g. progressive infection, uncontrolled diabetes, severe cardiac insufficiency or angina, severe liver dysfunction, etc.); 3. Patients participating in other clinical trials; 4. Failure to understand or comply with research programmes; 5. Other cases considered unsuitable for inclusion by the researchers.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of azactidine combined with PD-1 monoclonal antibody in the treatment of elderly patients with acute myeloid leukemia /myelodysplastic syndrome EB1/2.;	—

Secondary

Measure	Time frame
To evaluate safety of azactidine combined with PD-1 monoclonal antibody in the treatment of elderly patients with acute myeloid leukemia/myelodysplastic syndrome -EB1/2.;	—

Countries

China

Contacts

Public ContactGong Yuping

West China Hospital Shangjinnanfu Hospital

gongyuping@hotmail.com+86 18980601257

Outcome results

None listed

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