Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Ming Hou, Dr; Shandong University

More Information

• 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
• 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

Keywords provided by Ming Hou, Shandong University:

immune thrombocytopenia; Thrombocytopenia

Additional relevant MeSH terms:

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