Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

NCT ID: NCT03443570

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-03-01

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.

Conditions

Immune Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combination treatment group

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

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

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

Bortezomib

Intervention Type: DRUG

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

control group

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

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

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

Interventions

Rituximab

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

Intervention Type: DRUG

Bortezomib

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

Intervention Type: DRUG

Other Intervention Names

rituximab injection; velcade

Eligibility Criteria

Inclusion Criteria

1. Meet the diagnostic criteria for immune thrombocytopenia.

2. Not previously used rituximab and bortezomid,untreated patients, may be male or female, between the ages of 18 ~ 80 years.

3. To show a platelet count < 30×10^9/L, and with bleeding manifestations.

4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.

Exclusion Criteria

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.

2. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

3. 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)

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

5. 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou, Dr

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

Qilu hospital, Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Ming Hou, Dr

Role: CONTACT

houming@medmail.com.cn

+86-531-82169114 ext. 9879

Other Identifiers

RTX and bortezomib in ITP

Identifier Type: -

Identifier Source: org_study_id