Clinical trial NCT03443570: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Immune Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Keywords: immune thrombocytopenia
Thrombocytopenia
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Qingdao University
name: Yantai Yuhuangding Hospital
First posted: 2018-02-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluation of platelet response(continuous response rate)
timeFrame: up to 3 year per subject
Secondary outcomes:
measure: therapy associated adverse events
timeFrame: up to 3 year per subject
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital, Shandong University
state: Shandong
Study officials:
affiliation: Shandong University
name: Ming Hou, Dr
role: PRINCIPAL_INVESTIGATOR
References: