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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02487563
Other study ID # SOOCHOW-HY-2015
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2015
Est. completion date April 12, 2019

Study information

Verified date April 2020
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Isolated thrombocytopenia is a frequent and severe complication of hematopoietic stem cell transplantation (HSCT). It 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, including thrombopoietin, interleukin-11, immunoglobulin, methylprednisolone and rituximab, are frequently unsatisfactory in platelet recovery. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Thrombopoietin (TPO) is a cytokine that drives thrombopoiesis by stimulating the differentiation of stem cells into megakaryocytes and promoting megakaryocyte proliferation and polyploidization. Decitabine was approved for the treatment of myelodysplastic syndrome (MDS) as a DNA methylation inhibitors. Studies in vitro show that decitabine enhances platelet release and megakaryocyte maturation. Here, the investigators performed a prospective clinical trial, in order to investigate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date April 12, 2019
Est. primary completion date April 12, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 ?-? 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Decitabine
Decitabine
rhTPO
rhTPO
Other:
Conventional Treatment
immunoglobulin, glucocorticoid etc

Locations

Country Name City State
China The First affiliated Hospital of SooChow University Suzhou Jiangsu

Sponsors (9)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University 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

Country where clinical trial is conducted

China, 

References & Publications (3)

First LR, Smith BR, Lipton J, Nathan DG, Parkman R, Rappeport JM. Isolated thrombocytopenia after allogeneic bone marrow transplantation: existence of transient and chronic thrombocytopenic syndromes. Blood. 1985 Feb;65(2):368-74. — View Citation

Wang J, Yi Z, Wang S, Li Z. The effect of decitabine on megakaryocyte maturation and platelet release. Thromb Haemost. 2011 Aug;106(2):337-43. doi: 10.1160/TH10-11-0744. Epub 2011 Jun 28. — View Citation

Zhou H, Hou Y, Liu X, Qiu J, Feng Q, Wang Y, Zhang X, Min Y, Shao L, Liu X, Li G, Li L, Yang L, Xu S, Ni H, Peng J, Hou M. Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia. Throm — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Platelet Count Recovery Platelet response refers to a sustained increase (stable or increasing level) of at least 30×10E9/L independent of transfusion for 3 days. Up to 4 weeks after the treatment
Secondary Megakaryocyte Count The total number of megakaryocytes as well as the platelet-shedding megakaryocytes of bone marrow smears (per cm2) was counted and cross-checked by blinded observers. Up to 4 weeks after the treatment
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