Prospective Study of Patients With Thrombocytopenia Following HSCT

• Status: Completed
• Trial end date: 2019-04-12
• Target enrollment: 0
• Participant gender: All

Summary

Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Children's Hospital Of Soochow University; Fujian Medical University Union Hospital; Hebei Yanda Ludaopei Hospital; Nanfang Hospital of Southern Medical University; Peking University People's Hospital; Qilu Hospital of Shandong University; Ruijin Hospital; Wuhan Union Hospital, China
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

1. Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;

2. Neutrophil and hemoglobin were well recovered;

3. Full donor chimerism was achieved;

4. No response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks;

Exclusion Criteria:

1. Patients with malignancy relapse;

2. Active infections;

3. Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health criteria;

4. Severe organ damage;

5. Thrombosis requiring treatment;

6. Received decitabine following the current transplantation.