Stem Cell Transplant Complications Clinical Trial
Official title:
Azacitidine (AZA) Combined With N-Acetyl-L-cysteine (NAC) for Prolonged Isolated Thrombocytopenia (PIT) After Hematopoietic Stem Cell Transplantation (HSCT)
Prolonged isolated thrombocytopenia (PIT) that is refractory to conventional treatments has remained a critical complication after allogeneic hematopoietic cell transplantation since decades years ago. Recombinant human thrombopoietin (rhTPO) is the main therapy in clinical practice, but remains low efficiency for PIT. Demethylating drugs have shown thier potential in high-risk myelodysplastic syndromes (MDS) and acte myeloid leukemia (AML). In addition, decitabine has demonstrated its efficacy of over 70% for response rate in treatment for PIT in early clinical trials with elusive mechanism. Preliminary experiments revealed that PIT was associated with abnormality of oxidation microenvironment, and N-Acetyl-L-cysteine (NAC) was the most commonly used antioxidant. Therefore, the investigators have been wondering whether Azacitidine in combination with NAC could improve PIT post HSCT and explore the possible mechanism of it.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Platelet count = 30 × 10^9/L persistently at day 60 post-HSCT or later; - Neutrophil and hemoglobin were well recovered; - Full donor chimerism was achieved; Exclusion Criteria: - Patients with malignancy relapse; - Active infections; - Grade ?-? acute graft-versus-host disease or severe chronic graft-versus-host disease according to National Institute of Health criteria; - Severe organ damage; - Thrombosis requiring treatment; |
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University |
China,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | infection | clinical diagnose of infection or evidence of next generation of sequencing(NGS)of body fluid or CT or culture of samples collected from patients | From date of randomization until the date of diagnose of infection, assessed up to 100 days | |
Other | Severe adverse events | any events that prevent the clinical trial continue besides hepatic injury renal function impairment, et al. | From date of randomization until the date of occurrence of any severe adverse event, assessed up to 100 days | |
Primary | platelet reconstruction | platelet count above 50*10^9/L independent of transfusion | From date of randomization until the date of platelet reconstruction, assessed up to 100 days | |
Secondary | overall survival | the time from the date of day 1 post HSCT to the date of death due to any cause | From date of randomization until the date of death from any cause, assessed up to 1 year | |
Secondary | overall response rate | platelet count evaluating above 30*10^9/L but below 50*10^9/L independent of platelet transfusion | From date of randomization until the date of platelet count between 30*10^9/L and 50*10^9/L, assessed up to 100 days |
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