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DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients

Primary Purpose

Immune Thrombocytopenia

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

DEX Combined With RTX, CSA and IVIG

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Dexamethasone, Rituximab, Cyclosporin, Intravenous Immunoglobulin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
Untreated hospitalized patients, may be male or female, between the ages of 18 -60 years.
To show a platelet count < 30×10^9/L, and with bleeding manifestations.
Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
Willing and able to sign written informed consent

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 [2] 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. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

6.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.

7.Patients who are deemed unsuitable for the study by the investigator.

Sites / Locations

Qilu Hospital, Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

DEX Combined With RTX, CSA and IVIG All patients are assigned to receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.

Outcomes

Primary Outcome Measures

Evaluation of platelet response (Complete Response)

CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L

Evaluation of platelet response (Response)

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.

Evaluation of platelet response (No Response)

NR.No response (NR) was defined as 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.

Evaluation of platelet response (relapses)

A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.

Secondary Outcome Measures

The number and frequency of therapy associated adverse events

Full Information

NCT ID

NCT02834468

First Posted

July 13, 2016

Last Updated

July 13, 2016

Sponsor

Shandong University

Collaborators

Linyi People's Hospital, Liaocheng People's Hospital, Qingdao University

1. Study Identification

Unique Protocol Identification Number

NCT02834468

Brief Title

DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients

Official Title

A Multicenter Randomized Study of Dexamethasone Combined With Rituximab, Cyclosporin and Intravenous Immunoglobulin in the Management of Newly Diagnosed ITP Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

Linyi People's Hospital, Liaocheng People's Hospital, Qingdao University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project was undertaken by Qilu Hospital, Shandong University in China. In order to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed ITP patients.

Detailed Description

The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.

6. Conditions and Keywords

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

Immune Thrombocytopenia

Keywords

Dexamethasone, Rituximab, Cyclosporin, Intravenous Immunoglobulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

DEX Combined With RTX, CSA and IVIG

Other Intervention Name(s)

The combined therapy for ITP

Intervention Description

Primary Outcome Measure Information:

Title

Evaluation of platelet response (Complete Response)

Description

CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L

Time Frame

The time frame is up to 3 months per subject

Title

Evaluation of platelet response (Response)

Description

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.

Time Frame

The time frame is up to 3 months per subject

Title

Evaluation of platelet response (No Response)

Description

Time Frame

The time frame is up to 3 months per subject

Title

Evaluation of platelet response (relapses)

Description

A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.

Time Frame

The time frame is up to 9 months per subject

Secondary Outcome Measure Information:

Title

The number and frequency of therapy associated adverse events

Time Frame

up to 9 months per subject

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. Untreated hospitalized patients, may be male or female, between the ages of 18 -60 years. To show a platelet count < 30×10^9/L, and with bleeding manifestations. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2. Willing and able to sign written informed consent 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 [2] 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. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6.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. 7.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

Phone

86-531-82169879

qlhouming@sina.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou

Organizational Affiliation

Qilu Hospital, Shandong University

Official's Role

Study Chair

Facility Information:

Facility Name

Qilu Hospital, Shandong University

City

Jinan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yun Xiao Yang

Phone

86-531-82169114

qlyykyc@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18510702

Citation

Medeot M, Zaja F, Vianelli N, Battista M, Baccarani M, Patriarca F, Soldano F, Isola M, De Luca S, Fanin R. Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results. Eur J Haematol. 2008 Sep;81(3):165-9. doi: 10.1111/j.1600-0609.2008.01100.x. Epub 2008 May 27.

Results Reference

background

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

background

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DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients

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