AZA Combined With NAC for PIT After HSCT

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Azacitidine
  • N Acetyl L Cysteine

Treatment groups

100 Participants
are divided into 2 treatment groups