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

August 17, 2018 updated by: Ming Hou, Shandong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Shandong University Qilu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Decitabine
Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
Drug: Decitabine
Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet count
Time Frame: the third month after the first dose of decitabine
plate level at the third month after the first dose of decitabine
the third month after the first dose of decitabine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding score
Time Frame: at enrollment and the third month after the first dose of decitabine
the assessment of bleeding scores at enrollment and at the third month after the first dose of decitabine
at enrollment and the third month after the first dose of decitabine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Qingdao University
Shandong Provincial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2015

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (ESTIMATE)

April 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITP-Low-dose Decitabine
  • 81270578 (OTHER_GRANT: Natural Science Foundation of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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