Efficacy and safety of combined immunosuppressive therapy plus umbilical cord blood infusion in myelodysplastic syndromes/aplastic anemia patients: a clinical observation study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100047288

Enrollment

Unknown

Registered

2021-06-11

Start date

2021-06-01

Completion date

Unknown

Last updated

2022-02-01

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

Conditions

myelodysplastic syndromes/aplastic anemi

Interventions

Experimental group1:According to the classification, ATG + CsA/CSA alone is used as the pretreatment plan/supportive treatment + non-blood cord blood stem cell infusion treatment

Experimental group2:Decitabine+cytarabine/decitabine alone is used as the pretreatment plan/supportive treatment+non-blood cord blood stem cell infusion treatment according to the classification

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Signed written informed consent; 2.Diagnosed MDS/AA patients by both morphology and immunology; 3.Rule out other hematological diseases by morphology and molecular; 4.Aged >=18 years, regardless of gender or race; 5.Liver and renal function: serum bilirubin= 30g/L, creatinine clearance >60mL/min, creatinine<=150umol/L; 6.Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 7.Normal cardiac function: NYHA I/II; 8.Subjects have no uncontrolled infections.

Exclusion criteria

Exclusion criteria: 1.Patients with unresolved AML or refractory relapsed AML; 2.Allergy to any medication in the regimen; 3.Patients with a "currently active" second malignancy; 4.Liver and renal insufficiency (beyond the inclusion criteria); 5.Heart failure NYHA III/IV, severe arrhythmia and myocardial infarction; 6.Patients with other hematological disease; 7.Active tuberculosis patients and HIV-positive patients, active hepatitis, any other uncontrolled viral infections; 8.There are high-dose immunosuppressants or steroid drugs used for other diseases; 9.Patients participated in other clinical trial; 10.Patients who can't understand or obey the protocol; 11.There are other conditions judged by the doctor that are not suitable for inclusion in clinical research.

Design outcomes

Primary

Measure	Time frame
Frequency of blood transfusion;Reticulocyte count;Bone marrow hyperplasia degree;Neutrophil absolute value>0.5×10^9/L median time;Median time of platelet count> 20×10^9 /L;Incidence of infection;Infection fatality rate;	—

Secondary

Measure	Time frame
Disease-free survival;Overall survival rate;Early mortality rate;	—

Countries

China

Contacts

Public ContactLiu Jie

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

lieujie@163.com+86 18092662371

Outcome results

None listed

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