Back to results

Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

Primary Purpose

Immune Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Rituximab

Bortezomib

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring immune thrombocytopenia, Thrombocytopenia

Eligibility Criteria

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

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
Not previously used rituximab and bortezomid,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.
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

control group

Arm Description

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

100 enrolled patients are randomly picked up to take rituximabalone 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

NCT03443570

First Posted

February 18, 2018

Last Updated

February 18, 2018

Sponsor

Shandong University

Collaborators

The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03443570

Brief Title

Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Anticipated)

Primary Completion Date

March 1, 2020 (Anticipated)

Study Completion Date

March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other 2 well-known hospitals in China. In order to report the efficacy and safety of rituximab combining with bortezomib for the treatment of adults with immune thrombocytopenia (ITP), compared to rituximab alone .

Detailed Description

The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 100 ITP adult patients from 3 medical centers in China. One part of the participants are randomly selected to receive rituximab (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally) combining with bortezomib (given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally), the others are selected to receive rituximab alone (given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally). 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 rituximab 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

Immune Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic

Keywords

immune thrombocytopenia, Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

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 rituximab in combination with bortezomib at the indicated dose

Arm Title

control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

rituximab injection

Intervention Description

given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

velcade

Intervention Description

given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally

Primary Outcome Measure Information:

Title

Evaluation of platelet response(continuous response rate)

Description

Time Frame

up to 3 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 3 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. Not previously used rituximab and bortezomid,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. 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

Learn more about this trial

Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

We'll reach out to this number within 24 hrs