Rituximab Combining Bortezomib Versus Rituximab in Management of ITP
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ClinicalTrials.gov Identifier: NCT03443570 |
Recruitment Status : Unknown
Verified February 2018 by Ming Hou, Shandong University.
Recruitment status was: Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Immune Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic | Drug: Rituximab Drug: Bortezomib | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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) |
Estimated Study Start Date : | March 1, 2018 |
Estimated Primary Completion Date : | March 1, 2020 |
Estimated Study Completion Date : | March 1, 2021 |

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
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Drug: Rituximab
given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally
Other Name: rituximab injection Drug: Bortezomib given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally
Other Name: velcade |
Active Comparator: control group
100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose
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Drug: Rituximab
given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally
Other Name: rituximab injection |
- Evaluation of platelet response(continuous response rate) [ Time Frame: 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.
- therapy associated adverse events [ Time Frame: up to 3 year per subject ]The number and frequency of therapy associated adverse events

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443570
Contact: Ming Hou, Dr | +86-531-82169114 ext 9879 | houming@medmail.com.cn |
China, Shandong | |
Qilu hospital, Shandong University | |
Jinan, Shandong, China, 250012 |
Principal Investigator: | Ming Hou, Dr | Shandong University |
Responsible Party: | Ming Hou, Professor and Director, Shandong University |
ClinicalTrials.gov Identifier: | NCT03443570 |
Other Study ID Numbers: |
RTX and bortezomib in ITP |
First Posted: | February 23, 2018 Key Record Dates |
Last Update Posted: | February 23, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
immune thrombocytopenia Thrombocytopenia |
Thrombocytopenia Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Platelet Disorders Hematologic Diseases Blood Coagulation Disorders Hemorrhage Pathologic Processes Skin Manifestations Thrombotic Microangiopathies |
Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Rituximab Bortezomib Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |