Phase 3
N=97
Prospective Study of Patients With Thrombocytopenia Following HSCT
Thrombocytopenia · Hematologic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02487563 ↗Enrolled (actual)
97
Serious AEs
8.8%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Platelet Count Recovery — 20; 22; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Decitabine (Drug); rhTPO (Drug); Conventional Treatment (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- The First Affiliated Hospital of Soochow University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Platelet Count Recovery |
20; 22; 6 | — |
| SECONDARY Megakaryocyte Count |
6.7; 7.5; 3.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;
- Neutrophil and hemoglobin were well recovered;
- Full donor chimerism was achieved;
- No response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks;
Exclusion Criteria
- Patients with malignancy relapse;
- Active infections;
- Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health criteria;
- Severe organ damage;
- Thrombosis requiring treatment;
- Received decitabine following the current transplantation.
Data sourced from ClinicalTrials.gov (NCT02487563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.