Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

Shandong University

Status and phase: Unknown; Phase 3

Conditions: Purpura, Thrombocytopenic, Idiopathic; Immune Thrombocytopenia

Treatments: Drug: Bortezomib; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT03443570

RTX and bortezomib in ITP

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

combination treatment group

Experimental group

Description:

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

Treatment:

Drug: Bortezomib

Drug: Rituximab

control group

Active Comparator group

Description:

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

Treatment:

Drug: Rituximab