Immune Thrombocytopenic PurpuraITPNCT01719692
Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
A study testing Rituximab in people with Immune Thrombocytopenic Purpura, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Feb 2016
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years old;
- Diagnosis of primary immune thrombocytopenia according to the guidelines of American Society of Hematology for at least 3 months before inclusion;
- Platelet count <30×109/L (measured at least twice during the screening, with at least a 1-week interval);
- Failed or dependent on or relapsed after previous treatment with glucocorticoid;
- If on glucocorticoid maintenance therapy, dose ≤0.5 mg/kg prednisone or equivalent and stabilised for at least 4 weeks;
- Drugs such as azathioprine, danazol, cyclosporine A, tacrolimus, and sirolimus stopped for at least 4 weeks;
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- Splenectomy more than 6 months previously;
- Previous rescue therapy of ITP (including methylprednisolone, platelet transfusion and IVIG) completed at least 2 weeks before the first administration;
- Liver and kidney function (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatine, urea nitrogen, etc.) less than 1.5 times the upper limit of normal value;
- Eastern Cooperative Oncology Group performance status ≤2;
- Cardiac function classification (New York Heart Association) ≤2;
- Understand the research procedure and voluntarily sign a written informed consent form.
Who cannot join
- Patients with secondary thrombocytopenia (including myelodysplastic syndrome, aplastic anemia, common variant immunodeficiency disease, hereditary thrombocytopenia, drug-induced thrombocytopenia, pseudothrombocytopenia, connective tissue disease secondary thrombocytopenia, thrombocytopenia after liver disease, etc.);
- Previous treatment of RTX or allergic to RTX;
- Uncontrollable primary diseases of important organs (including malignant tumor, liver failure, heart failure, kidney failure and other diseases);
- HIV-positive status;
- Active infection including hepatitis B (HBV), hepatitis C (HCV) and other viral antigens or DNA, RNA positive; cytomegalovirus, Epstein-Barr virus, syphilis chronic or active infection. If HBV core antibodies are positive, HBV-DNA testing is required.
- Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.
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- Heart disease or arrhythmia need treatment, or poorly controlled hypertension;
- Thrombotic diseases including pulmonary embolism, thrombosis, atherosclerosis, etc.;
- Previously allogeneic stem cell transplantation or organ transplantation;
- Mental disorders who are unable to obtain informed consent normally and participate in trials and follow-up;
- Symptoms of toxicity from pre-trial treatment have not resolved;
- Other severe conditions that may limit participation in the trial (e.g., diabetes; severe cardiac insufficiency; myocardial infarction or unstable arrhythmia or unstable angina within the last 6 months; gastric ulcer; active autoimmune diseases, etc.);
- Sepsis or other irregular bleeding;
- Taking antiplatelet drugs;
- pregnancy, suspected pregnancy (urine human chorionic gonadotropin positive during screening) or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multi-center Randomized Controlled Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.
Read the detailed description
This is a multicentre, prospective, open-label, randomised controlled trial. The aim of this study will compare the long-term efficacy and safety of two low-dose rituximab regimens in adult Chinese patients with glucocorticoid-resistant/dependent or relapsed ITP. Group A will receive rituximab100 mg weekly for four weeks, and group B will receive rituximab 375 mg/m2 once. After initiating treatment, if the patient has at least two consecutive evaluations (interval >7 days) without rescue therapy and a platelet count >50×109/L, the concomitant medications such as glucocorticoids can be reduced or stopped.
Within 3 months of the last rituximab dose, rescue therapy is recommended if the patient has an extremely low platelet count and an obvious bleeding tendency. Rescue therapy is limited to IVIG (0.4 g/kg per day for 3-5 days) and glucocorticoid (methylprednisolone 0.8 mg/kg per day for 7-14 days or equivalent dose of other glucocorticoids).
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- Rituximab
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Trade names Rituxan and MabThera
| Study group | Role | What they receive |
|---|---|---|
| Rituximab A group | Experimental | 375mg/m2 for once Receives: Drug: Rituximab |
| Rituximab B group | Active comparator | 100mg/week for four weeks Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate at week 12
Overall response rate was defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least twice the baseline platelet count without bleeding and subjects with a platelet count ≥ 100 × 10^9/L without bleeding at week 12 after initial administration in absence of rescue therapy, and without having had dose increment of corticosteroids during the study period.
Measured: Patients will be followed for 6 months at least after Rituximab treatment.
Secondary outcomes (4)
Sustained response rate over 6 months and 1, 2, 3, 4, and 5 years after RTX initiation
Proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least twice the baseline platelet count without bleeding and subjects with a platelet count ≥ 100 × 10^9/L without bleeding at 6 months and 1, 2, 3, 4, and 5 years after initial administration in absence of rescue therapy
Measured: Patients will be followed for 6 months at least after Rituximab treatment.
Time to response (TTR)
Time needed from treatment initiation to platelet count ≥30×10^9/L and at least twice the baseline platelet count.
Measured: 6 months
Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale
Changes of the subjects' numbers in WHO bleeding score after RTX treatment according to the reported World Health Organization's Bleeding Scale at month 3. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
Measured: 3 months
Adverse events assessment
Incidence, severity, and relationship of treatment emergent adverse events during the study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Langfang Traditional Chinese Medicine Hospital, Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
- Investigators
- RENCHI YANG, Dr, Principal investigator, Hospital of Blood disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719692
- Sponsor's protocol ID
- IIT2012001
- Acronym
- ITP
- Status last verified
- Mar 2024
- First submitted
- 26 Oct 2012
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen Y, Liu J, Dai J, Sun T, Qiao Z, Wang M, Zhou H, Zhou Z, Liu X, Fu R, Xue F, Liu W, Ju M, Dong H, Dai X, Gu W, Yang R, Zhang L. Long-term efficacy and safety of low-dose rituximab in immune thrombocytopenia: a multicentre, prospective, open-label, randomised controlled trial. Ann Hematol. 2026 Feb 26;105(4):140. doi: 10.1007/s00277-026-06908-2.
PubMed 41741872
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Randomized Controlled Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT01719692
- Acronym / sponsor ID
- ITP / IIT2012001
- Conditions
- Immune Thrombocytopenic Purpura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Langfang Traditional Chinese Medicine Hospital, Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University
- Study start
- Oct 2012 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Nov 2012 (estimated)
- 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.
A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.
Detailed description
This is a multicentre, prospective, open-label, randomised controlled trial. The aim of this study will compare the long-term efficacy and safety of two low-dose rituximab regimens in adult Chinese patients with glucocorticoid-resistant/dependent or relapsed ITP. Group A will receive rituximab100 mg weekly for four weeks, and group B will receive rituximab 375 mg/m2 once. After initiating treatment, if the patient has at least two consecutive evaluations (interval >7 days) without rescue therapy and a platelet count >50×109/L, the concomitant medications such as glucocorticoids can be reduced or stopped.
Within 3 months of the last rituximab dose, rescue therapy is recommended if the patient has an extremely low platelet count and an obvious bleeding tendency. Rescue therapy is limited to IVIG (0.4 g/kg per day for 3-5 days) and glucocorticoid (methylprednisolone 0.8 mg/kg per day for 7-14 days or equivalent dose of other glucocorticoids).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab A group | Experimental | Drug: Rituximab375mg/m2 for once |
| Rituximab B group | Active comparator | Drug: Rituximab100mg/week for four weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 18-60 years old;
- Diagnosis of primary immune thrombocytopenia according to the guidelines of American Society of Hematology for at least 3 months before inclusion;
- Platelet count <30×109/L (measured at least twice during the screening, with at least a 1-week interval);
- Failed or dependent on or relapsed after previous treatment with glucocorticoid;
- If on glucocorticoid maintenance therapy, dose ≤0.5 mg/kg prednisone or equivalent and stabilised for at least 4 weeks;
Key exclusion criteria (15 listed)
- Patients with secondary thrombocytopenia (including myelodysplastic syndrome, aplastic anemia, common variant immunodeficiency disease, hereditary thrombocytopenia, drug-induced thrombocytopenia, pseudothrombocytopenia, connective tissue disease secondary thrombocytopenia, thrombocytopenia after liver disease, etc.);
- Previous treatment of RTX or allergic to RTX;
- Uncontrollable primary diseases of important organs (including malignant tumor, liver failure, heart failure, kidney failure and other diseases);
- HIV-positive status;
- Active infection including hepatitis B (HBV), hepatitis C (HCV) and other viral antigens or DNA, RNA positive; cytomegalovirus, Epstein-Barr virus, syphilis chronic or active infection. If HBV core antibodies are positive, HBV-DNA testing is required.
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: Trade names Rituxan and MabThera | Drug | Rituximab A group, Rituximab B group |
Primary outcome
Overall response rate at week 12
Time frame: Patients will be followed for 6 months at least after Rituximab treatment.
Overall response rate was defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least twice the baseline platelet count without bleeding and subjects with a platelet count ≥ 100 × 10^9/L without bleeding at week 12 after initial administration in absence of rescue therapy, and without having had dose increment of corticosteroids during the study period.
4 secondary outcomes
Sustained response rate over 6 months and 1, 2, 3, 4, and 5 years after RTX initiation
Time frame: Patients will be followed for 6 months at least after Rituximab treatment.
Time to response (TTR)
Time frame: 6 months
Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale
Time frame: 3 months
Adverse events assessment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Derived from this study: PubMed 41741872Chen Y, Liu J, Dai J, Sun T, Qiao Z, Wang M, Zhou H, Zhou Z, Liu X, Fu R, Xue F, Liu W, Ju M, Dong H, Dai X, Gu W, Yang R, Zhang L. Long-term efficacy and safety of low-dose rituximab in immune thrombocytopenia: a multicentre, prospective, open-label, randomised controlled trial. Ann Hematol. 2026 Feb 26;105(4):140. doi: 10.1007/s00277-026-06908-2.
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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.
RENCHI YANG, Dr principal investigator
Hospital of Blood disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab in people with Immune Thrombocytopenic Purpura, run by Institute of Hematology & Blood Diseases Hospital, China 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 12 inclusion and 15 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: finished, as of the sponsor's last update on 11 Feb 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate at week 12 (time frame: Patients will be followed for 6 months at least after Rituximab treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719692, which also lists 1 linked publication.
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 11 Feb 2026.