Camrelizumab Combined with Decitabine in Patients with Higher-Risk Myelodysplastic Syndrome after Failure of Hypomethylating Agent Therapy: a Open, One Arm, Multi-Center, Exploratory Study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100044210

Enrollment

Unknown

Registered

2021-03-12

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

Myelodysplastic Syndromes

Interventions

single arm:Camrelizumab combined with Decitabine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as EB-1 and EB-2 according to WHO(2016) who have failed or relapsed after at least 4 courses of treatment with HMA (desicitabine or azacytidine); 2. Eastern Cooperative Oncology Group (ECOG) performance of 0 to 2; 3. Adequate hepatic and renal function as measured by the following pretreatment laboratory criteria: Serum Creatinine <=1.5 ULN; Blood Urea Nitrogen<=1.5 ULN; serum glutamic phyuvic transaminase<=2 ULN; 4. Subjects must have signed an informed consent document.

Exclusion criteria

Exclusion criteria: 1. Has received an investigational drug within 30 days preceding the first dose of study drug; 2. A history of tumor and accept any the treatment for the tumor in the past three years; 3. Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses (prednisolone= 10^3copies/ml) or hepatitis C virus ribonucleic acid (HCV antibody positive, and HCV RNA) indicating acute or chronic infection; 5. Has active autoimmune disease; 6. Receive systemic hormones for a long time (doses equivalent to > 10mg prednisone/day) or any other form of immunosuppressive therapy; 7. Has active viral or bacterial infection, and has uncontrolled infection by using appropriate anti-infection; 8. Has known positive serology for HIV; 9. Suffering from mental disorders or other conditions and unable to meet the requirements of research, treatment and monitoring; 10. Has inaspirable bone marrow; 11. Has known hypersensitivity to any of the excipients of Decitabine and Camrelizumab; 12. Received hematopoietic stem cell transplantation in the past year.

Design outcomes

Primary

Measure	Time frame
overall response rate;	—

Secondary

Measure	Time frame
cytogenetic response rates;Overall Survival;Progression Free Survival;Quality of life (QOL);expression level of PD1/PDL1;	—

Countries

China

Contacts

Public ContactZhijian Xiao

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

zjxiao@ihcams.ac.cn+86 22 23909184

Outcome results

None listed

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