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Prospective Study of Patients With Thrombocytopenia Following HSCT

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ClinicalTrials.gov Identifier: NCT02487563
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
Peking University People's Hospital
Nanfang Hospital of Southern Medical University
Ruijin Hospital
Wuhan Union Hospital, China
Qilu Hospital of Shandong University
Children's Hospital Of Soochow University
Fujian Medical University Union Hospital
Hebei Yanda Ludaopei Hospital
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Brief 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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Hematologic Diseases Drug: Decitabine Drug: rhTPO Other: Conventional Treatment Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Patients With Isolated Thrombocytopenia Following Hematopoietic Stem Cell Transplantation
Study Start Date : October 2015
Actual Primary Completion Date : April 12, 2019
Actual Study Completion Date : April 12, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: Experimental Group 1
Decitabine in combination with rhTPO.
Drug: Decitabine
Decitabine
Other Name: 5-Aza-2'-deoxycytidine

Drug: rhTPO
rhTPO
Other Name: Thrombopoietin

Experimental: Experimental Group 2
Decitabine
Drug: Decitabine
Decitabine
Other Name: 5-Aza-2'-deoxycytidine

Active Comparator: Control Group
Conventional treatment except decitabine.
Other: Conventional Treatment
immunoglobulin, glucocorticoid etc




Primary Outcome Measures :
  1. Number of Participants With Platelet Count Recovery [ Time Frame: Up to 4 weeks after the treatment ]
    Platelet response refers to a sustained increase (stable or increasing level) of at least 30×10E9/L independent of transfusion for 3 days.


Secondary Outcome Measures :
  1. Megakaryocyte Count [ Time Frame: Up to 4 weeks after the treatment ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487563


Locations
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China, Jiangsu
The First affiliated Hospital of SooChow University
Suzhou, Jiangsu, China, 215000
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Peking University People's Hospital
Nanfang Hospital of Southern Medical University
Ruijin Hospital
Wuhan Union Hospital, China
Qilu Hospital of Shandong University
Children's Hospital Of Soochow University
Fujian Medical University Union Hospital
Hebei Yanda Ludaopei Hospital
Investigators
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Study Chair: Depei Wu, PhD,MD The First Affiliated Hospital of Soochow University
  Study Documents (Full-Text)

Documents provided by The First Affiliated Hospital of Soochow University:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02487563    
Other Study ID Numbers: SOOCHOW-HY-2015
First Posted: July 1, 2015    Key Record Dates
Results First Posted: May 6, 2020
Last Update Posted: May 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The First Affiliated Hospital of Soochow University:
Isolated thrombocytopenia
decitabine
rhTPO
Additional relevant MeSH terms:
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Thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors