AZA Combined With NAC for PIT After HSCT

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Acetylcysteine; Azacitidine; N-monoacetylcystine

Criteria

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 Ⅲ-Ⅳ 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;