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Completed

NCT Number: NCT01568333

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

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.

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Key information

Conditions

Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shandong University Qilu hospital

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decitabine

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Qingdao University
  • Shandong Provincial Hospital

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 2, 2012
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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