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| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
| Yantai Yuhuangding Hospital | OTHER |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination treatment group | Experimental | 100 enrolled patients are randomly picked up to take rituximab in combination with bortezomib at the indicated dose |
|
| control group | Active Comparator | 100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 3 year per subject |
| Measure | Description | Time Frame |
|---|---|---|
| therapy associated adverse events | The number and frequency of therapy associated adverse events | up to 3 year per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Hou, Dr | Contact | +86-531-82169114 | 9879 | houming@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Hou, Dr | Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital, Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Bortezomib | Drug | given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally |
|
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |