Rituximab Combining Bortezomib Versus Rituximab in Management of ITP

NCT03443570 | Unknown Phase 3 DMC

• 1 other identifier: RTX and bortezomib in ITP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 .

Conditions

Immune Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic

Keywords

immune thrombocytopenia; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• therapy associated adverse events

  up to 3 year per subject

Study Arms (2)

combination treatment group

EXPERIMENTAL

100 enrolled patients are randomly picked up to take rituximab in combination with bortezomib at the indicated dose

Drug: Rituximab; Drug: Bortezomib

control group

ACTIVE COMPARATOR

100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose

Drug: Rituximab

Interventions

Rituximab DRUG

given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally

Also known as: rituximab injection

combination treatment group; control group

Bortezomib DRUG

given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally

Also known as: velcade

combination treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead
• The Affiliated Hospital of Qingdao University: collaborator
• Yantai Yuhuangding Hospital: collaborator

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia

Interventions

Rituximab; Bortezomib

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ming Hou, Dr

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou, Dr

CONTACT

+86-531-82169114; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: February 23, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)