Last updated: October 11, 2021
Sponsor: Xiao-Jun Huang
Overall Status: Active - Recruiting
Phase
1
Condition
Allogeneic Hematopoietic Stem Cell Transplant
Cytomegalovirus Infections
Allo-hematopoietic Stem Cell Transplant
Treatment
N/AClinical Study ID
NCT05089838
2020PHD014-001
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with acute leukemia (AL) or myelodysplastic syndrome (MDS) who receivehaploid allogeneic hematopoietic stem cell transplantation, pre-transplantationassessment ≤CR2;
- Age 18-60, including boundary value, gender unlimited;
- Refractory CMV infection occurred in the early stage of transplantation : After 2weeks of standard antiviral treatment, the CMV DNA copy number continued to be ≥1000copies/mL, and the CMV DNA copy number at the beginning of the treatment decreased by <log10 ;
- The transplant donor's HLA-A matching is one of 2402, 0201 or 1101, and the physicalexamination is qualified;
- ECOG ≤ 3, estimated life expectancy> 3 months;
- Patients who voluntarily sign informed consent and are willing to comply withtreatment plans, visit arrangements, laboratory tests and other research procedures.
Exclusion
Exclusion Criteria:
- Patients with active aGVHD III-IV and / or mild and severe cGVHD;
- Have received cell therapy such as DLI, CTL, CAR-T, NK or participated in any otherclinical research on drugs and medical devices;
- Patients who have developed CMV disease;
- patients with organ failure:
- Heart: NYHA heart function grade IV;
- Liver: Grade C that achieves Child-Turcotte liver function grading;
- Kidney: kidney failure and uremia;
- Lung: symptoms of respiratory failure;
- Brain: a person with a disability;
- Pregnant or lactating women;
- The researchers found that it was unsuitable for the recipients to be enrolled.
Study Design
Total Participants: 12
Study Start date:
January 06, 2021
Estimated Completion Date:
October 31, 2023
Study Description
Connect with a study center
Peking University Institute of Hematology,People's hospital Peking University
Beijing, Beijing 100044
ChinaActive - Recruiting

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