Back to results

Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

Primary Purpose

Purpura, Thrombocytopenic, Idiopathic, Immune Thrombocytopenia

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Decitabine

Dexamethasone

About this trial

This is an interventional treatment trial for Purpura, Thrombocytopenic, Idiopathic focused on measuring Purpura, Thrombocytopenia, immune throbocytopenia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
within 3 months fromdiagnosis,untreated patients, may be male or female, between the ages of 18 ~ 80 years.
To show a platelet count < 30×10^9/L, and with bleeding manifestations.
Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study.
Current HIV infection or hepatitis B virus or hepatitis C virus infections.
Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
Patients who are deemed unsuitable for the study by the investigator.

Sites / Locations

Qilu hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combination treatment group

single treatment group

Arm Description

100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose

100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose

Outcomes

Primary Outcome Measures

Evaluation of platelet response(continuous response rate)

Complete Response:a sustained (≥ 3 months) platelet count ≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.

Secondary Outcome Measures

therapy associated adverse events

The number and frequency of therapy associated adverse events

Full Information

NCT ID

NCT03252457

First Posted

August 14, 2017

Last Updated

August 13, 2018

Sponsor

Shandong University

Collaborators

Second Affiliated Hospital of Medical College Shandong University, Shandong Provincial Hospital, Qingdao Central Hospital, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03252457

Brief Title

Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

Official Title

A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Anticipated)

Primary Completion Date

December 1, 2020 (Anticipated)

Study Completion Date

December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

Second Affiliated Hospital of Medical College Shandong University, Shandong Provincial Hospital, Qingdao Central Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known hospitals in China. In order to report the efficacy and safety of decitabine combining with dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to dexamethasone alone .

Detailed Description

The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 200 ITP adult patients from 19 medical centers in China. One part of the participants are randomly selected to receive dexamethasone (given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given) combining with decitabine (given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3 cycles), the others are selected to receive dexamethasone therapy(given 40mg/d for 4 consecutive days as a cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given). Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to dexemathasone alone therapy for the treatment of adults with ITP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Purpura, Thrombocytopenic, Idiopathic, Immune Thrombocytopenia

Keywords

Purpura, Thrombocytopenia, immune throbocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

combination treatment group

Arm Type

Experimental

Arm Description

100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose

Arm Title

single treatment group

Arm Type

Active Comparator

Arm Description

100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose

Intervention Type

Drug

Intervention Name(s)

Decitabine

Other Intervention Name(s)

pharmachemie

Intervention Description

given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Hydrocortisone

Intervention Description

given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.

Primary Outcome Measure Information:

Title

Evaluation of platelet response(continuous response rate)

Description

Time Frame

up to 1 year per subject

Secondary Outcome Measure Information:

Title

therapy associated adverse events

Description

The number and frequency of therapy associated adverse events

Time Frame

up to 1 year per subject

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. within 3 months fromdiagnosis,untreated patients, may be male or female, between the ages of 18 ~ 80 years. To show a platelet count < 30×10^9/L, and with bleeding manifestations. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2. Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. Patients who are deemed unsuitable for the study by the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Hou, Dr

Phone

+86-531-82169114

Ext

9879

houming@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou, Dr

Organizational Affiliation

Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qilu hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19005182

Citation

Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

Results Reference

result

PubMed Identifier

25566808

Citation

Zhou H, Hou Y, Liu X, Qiu J, Feng Q, Wang Y, Zhang X, Min Y, Shao L, Liu X, Li G, Li L, Yang L, Xu S, Ni H, Peng J, Hou M. Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia. Thromb Haemost. 2015 May;113(5):1021-34. doi: 10.1160/TH14-04-0342. Epub 2015 Jan 8.

Results Reference

result

PubMed Identifier

26480931

Citation

Wei Y, Ji XB, Wang YW, Wang JX, Yang EQ, Wang ZC, Sang YQ, Bi ZM, Ren CA, Zhou F, Liu GQ, Peng J, Hou M. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016 Jan 21;127(3):296-302; quiz 370. doi: 10.1182/blood-2015-07-659656. Epub 2015 Oct 19.

Results Reference

result

PubMed Identifier

25247485

Citation

Din B, Wang X, Shi Y, Li Y. Long-term effect of high-dose dexamethasone with or without low-dose dexamethasone maintenance in untreated immune thrombocytopenia. Acta Haematol. 2015;133(1):124-8. doi: 10.1159/000362529. Epub 2014 Sep 20.

Results Reference

result

Learn more about this trial

Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

We'll reach out to this number within 24 hrs