Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

Sponsor

Shandong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03443570

Collaborator

The Affiliated Hospital of Qingdao University (Other), Yantai Yuhuangding Hospital (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic	Drug: Rituximab Drug: Bortezomib	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: combination treatment group 100 enrolled patients are randomly picked up to take rituximab in combination with bortezomib at the indicated dose	Drug: Rituximab given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally Other Names: rituximab injection Drug: Bortezomib given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally Other Names: velcade
Active Comparator: control group 100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose	Drug: Rituximab given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally Other Names: rituximab injection

Arm

Intervention/Treatment

Experimental: combination treatment group

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

Drug: Rituximab

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

Other Names:

rituximab injection

Drug: Bortezomib

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

Other Names:

velcade

Active Comparator: control group

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

Drug: Rituximab

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

Other Names:

rituximab injection

Outcome Measures

Primary Outcome Measures

Evaluation of platelet response(continuous response rate) [up to 3 year per subject]
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 [up to 3 year per subject]
The number and frequency of therapy associated adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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