Immune ThrombocytopeniaPhase 3NCT03443570
Rituximab Combining Bortezomib Versus Rituximab in Management of ITP
A Phase 3 study testing Rituximab and Bortezomib in people with Immune Thrombocytopenia and Purpura, Thrombocytopenic, Idiopathic, run by Shandong University at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- Rituximab and Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Prospective Randomized Study of Rituximab Combined With Bortezomib Versus Rituximab in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
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 .
Read the 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.
- Being tested
- Rituximab, Bortezomib
- Keywords
- immune thrombocytopenia, Thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called rituximab injection
given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally
BortezomibDrug
Also called velcade
given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally
| Study group | Role | What they receive |
|---|---|---|
| combination treatment group | Experimental | 100 enrolled patients are randomly picked up to take rituximab in combination with bortezomib at the indicated dose Receives: Drug: Rituximab; Drug: Bortezomib |
| control group | Active comparator | 100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 year per subject
Secondary outcomes (1)
therapy associated adverse events
The number and frequency of therapy associated adverse events
Measured: up to 3 year per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou, Dr, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443570
- Sponsor's protocol ID
- RTX and bortezomib in ITP
- Status last verified
- Feb 2018
- First submitted
- 18 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Study of Rituximab Combined With Bortezomib Versus Rituximab in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT03443570
- Acronym / sponsor ID
- RTX and bortezomib in ITP
- Keywords
- immune thrombocytopenia, Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination treatment group | Experimental | Drug: Rituximab, Drug: Bortezomib100 enrolled patients are randomly picked up to take rituximab in combination with bortezomib at the indicated dose |
| control group | Active comparator | Drug: Rituximab100 enrolled patients are randomly picked up to take rituximabalone at the indicated dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: rituximab injectiongiven with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally | Drug | combination treatment group, control group |
| BortezomibAlso: velcadegiven subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally | Drug | combination treatment group |
Primary outcome
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.
1 secondary outcome
therapy associated adverse events
Time frame: up to 3 year per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Immune Thrombocytopenia
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Hou, Dr principal investigator
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab and Bortezomib in people with Immune Thrombocytopenia and Purpura, Thrombocytopenic, Idiopathic, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Hou, Dr (+86-531-82169114 ext. 9879, houming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of platelet response(continuous response rate) (time frame: up to 3 year per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.