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Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

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ClinicalTrials.gov Identifier: NCT03443570
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
The Affiliated Hospital of Qingdao University
Yantai Yuhuangding Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

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.

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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
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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Ming Hou, Dr +86-531-82169114 ext 9879 houming@medmail.com.cn

Locations
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China, Shandong
Qilu hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
The Affiliated Hospital of Qingdao University
Yantai Yuhuangding Hospital
Investigators
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Principal Investigator: Ming Hou, Dr Shandong University

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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT03443570     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ming Hou, Shandong University:
immune thrombocytopenia
Thrombocytopenia

Additional relevant MeSH terms:
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Thrombocytopenia
Purpura
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Rituximab
Bortezomib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents