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Azacytidine combined with immuno-detection point inhibitor (Cindigomab) in the treatment of elderly acute myeloid leukemia with increased leukemia residual disease or recurrent after microtransplantation: a single-center prospective non-randomized controlled clinical trial

Azacytidine combined with immuno-detection point inhibitor (Cindigomab) in the treatment of elderly acute myeloid leukemia with increased leukemia residual disease or recurrent after microtransplantation: a single-center prospective non-randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025147
Enrollment
Unknown
Registered
2019-08-14
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Acute myeloid leukemia

Interventions

experimental group:Azacytidine combined with PD-1 monoclonal antibody
Control Group:Azacytidine

Sponsors

Bone Marrow Transplantation Center of the First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The age is 60 to 75 years old, gender is not limited, race is not limited. 2. Diagnosed as AML according to the diagnostic criteria of WHO in 2016. 3. Patients who have previously received microtransplantation (third-party hematopoietic stem cell infusion with mismatched HLA) and achieved complete remission. 4. Physical status = 40mL/min. 8. The LVEF measured by echocardiography was in the normal range (LVEF > 50%). 9. Each patient (or his or her legal representative) must sign an informed consent form (ICF), indicating that he / she understands the purpose and procedures of the study and is willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Diagnosed or receiving treatment for other malignant tumors other than AML that are or are in need of treatment in the near future. 2. Acute promyelocytic leukemia, myeloid sarcomas, accelerated and acute transformation of chronic myeloid leukemia. 3. Patients with severe liver and kidney function, cardiopulmonary insufficiency. 4. Uncontrolled or severe infection. 5. Mental illness that may prevent subjects from completing treatment or informed consent.

Design outcomes

Primary

MeasureTime frame
complete remisson;bone marrow complete remisson;—

Secondary

MeasureTime frame
Partial remission;Median disease-free survival rate;2-year disease-free survival rate;2-year overall survival rate;Hematopoietic cell recovery time;Early mortality rate;Chimera / microchimerism evaluation;Minimal residual disease;—

Countries

China

Contacts

Public ContactJie Sun

Bone Marrow Transplantation Center of the First Affiliated Hospital,College of Medicine, Zhejiang University

jsun1492@zju.edu.cn+86 15305714109

Outcome results

None listed

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