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

NCT01568333 | Completed Phase 2 DMC

• 2 other identifiers: ITP-Low-dose Decitabine81270578
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Keywords

Decitabine; Immune thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Platelet count

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

  the third month after the first dose of decitabine

Secondary Outcomes (1)

• Bleeding score

  at enrollment and the third month after the first dose of decitabine

Study Arms (1)

Decitabine

EXPERIMENTAL

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

Drug: Decitabine

Interventions

Decitabine DRUG

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

Decitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead
• Qingdao University: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Shandong University Qilu hospital

Jinan, Shandong, 250012, China

Location

Related Publications (3)

• 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.

  PMID: 15203276 BACKGROUND

• 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.

  PMID: 21713321 BACKGROUND

• 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.

  PMID: 31591739 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Decitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Ming Hou

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: August 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

CN (1)