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A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia

Primary Purpose

Immune Thrombocytopenia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Decitabine
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Decitabine, Immune thrombocytopenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients with the diagnosis of ITP according to the International Working Group (IWG) guidelines
  • failure to splenectomy or at least four standard ITP-specific treatments, but not necessarily undergone splenectomye
  • baseline peripheral platelet count less than 30,000/uL or the presence of bleeding symptoms
  • need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or

Exclusion Criteria:

  • secondary ITP
  • pregnancy
  • hypertension
  • cardiovascular disease
  • diabetes
  • liver and kidney function impairment
  • HCV, HIV, HBsAg seropositive status
  • patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Sites / Locations

  • Shandong University Qilu hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decitabine

Arm Description

Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.

Outcomes

Primary Outcome Measures

Platelet count
plate level at the third month after the first dose of decitabine

Secondary Outcome Measures

Bleeding score
the assessment of bleeding scores at enrollment and at the third month after the first dose of decitabine

Full Information

First Posted
March 29, 2012
Last Updated
August 17, 2018
Sponsor
Shandong University
Collaborators
Qingdao University, Shandong Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01568333
Brief Title
A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Official Title
A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
Qingdao University, Shandong Provincial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Decitabine has been reported to have a clinically significant, often long lasting effect on the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine could increase platelet counts by enhancing megakaryocyte maturation and platelet release. Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of decitabine in the treatment of ITP.
Detailed Description
The investigators are undertaking a multicenter, single-arm study of primary ITP adult patients from 9 medical centers in China. All the participants are selected to receive low-dose of decitabine treatment (given intravenously at a dose of 3.5mg/m2 for 3 days per cycle for 3 cycles). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Decitabine, Immune thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decitabine
Arm Type
Experimental
Arm Description
Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
Primary Outcome Measure Information:
Title
Platelet count
Description
plate level at the third month after the first dose of decitabine
Time Frame
the third month after the first dose of decitabine
Secondary Outcome Measure Information:
Title
Bleeding score
Description
the assessment of bleeding scores at enrollment and at the third month after the first dose of decitabine
Time Frame
at enrollment and the third month after the first dose of decitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients with the diagnosis of ITP according to the International Working Group (IWG) guidelines failure to splenectomy or at least four standard ITP-specific treatments, but not necessarily undergone splenectomye baseline peripheral platelet count less than 30,000/uL or the presence of bleeding symptoms need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or Exclusion Criteria: secondary ITP pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong University Qilu hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15203276
Citation
van den Bosch J, Lubbert M, Verhoef G, Wijermans PW. The effects of 5-aza-2'-deoxycytidine (Decitabine) on the platelet count in patients with intermediate and high-risk myelodysplastic syndromes. Leuk Res. 2004 Aug;28(8):785-90. doi: 10.1016/j.leukres.2003.11.016.
Results Reference
background
PubMed Identifier
21713321
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.
Results Reference
background
PubMed Identifier
31591739
Citation
Zhou H, Qin P, Liu Q, Yuan C, Hao Y, Zhang H, Wang Z, Ran X, Chu X, Yu W, Wang X, Hou Y, Peng J, Hou M. A prospective, multicenter study of low dose decitabine in adult patients with refractory immune thrombocytopenia. Am J Hematol. 2019 Dec;94(12):1374-1381. doi: 10.1002/ajh.25646. Epub 2019 Oct 17.
Results Reference
derived

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A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia

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