Immune ThrombocytopeniaPhase 2NCT07362199
Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
A Phase 2 study testing Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody） in people with Immune Thrombocytopenia and Treatment, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined with Rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia, Treatment
- What is being tested?
- Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, male or female.
- Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.
- Subjects have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Subjects have failed at least one prior thrombopoietin receptor agonist therapy (such as rhTPO, eltrombopag, hetrombopag, etc.) in second-line treatment, as well as rituximab/anti-CD38 monoclonal antibody therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Alternatively, subjects have experienced treatment failure or post-splenectomy relapse following splenectomy.
- Subjects with a platelet count of <30×10^9/L within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) <30×10^9/L during the screening visit, and no platelet count > 35×10^9/L.
- ECOG performance status score of ≤2.
- Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.
- For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4 or 6 months after the cessation of study drug treatment.
- Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.
Who cannot join
- Subjects allergic to CD20 monoclonal antibody or CD38 monoclonal antibody.
- Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.
- Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.
- Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.
- Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.
- Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.
Show all 26Show fewer
- Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have been treated with CD20 monoclonal antibodies (e.g., rituximab), CD38 monoclonal antibodies, cyclophosphamide, vindesine, or similar medications within 3 months prior to the first dose of study drug.
- Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.
- Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.
- Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).
- Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.
- Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;
- Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.
- Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).
- Significant laboratory abnormalities during screening included:
- Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).
- Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).
- absolute neutrophil count < 1500/mm3.
- hemoglobin < 9g/dL.
- IgG < 500 mg/dL.
- lymphocyte count < 500/mm3.
- Creatinine clearance (CrCl) < 30 mL/min (i.e., CrCl ≥30 mL/min is allowed)
- Positive for HIV antibodies or syphilis antibodies.
- Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.
- Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.
- Any other conditions unsuitable for participation in this study, as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, 300020
Lei Zhang, MD, +8602223909009, zhanglei1@ihcams.ac.cn
Yunfei Chen, MD, +8602223608180, chenyunfei@ihcams.ac.cn
About this study
Official title: A Single-arm, Open-label Phase II Clinical Study Evaluating the Efficacy of Rituximab Combined With Anti-CD38 Monoclonal Antibody in the Treatment of Primary Immune Thrombocytopenia (ITP)
This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined with Rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Read the detailed description
Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a considerable number of patients need drug maintenance treatment, which seriously affects the quality of life of patients and increases the economic burden of patients. Therefore, there is still a lack of effective treatment for adult ITP, especially for recurrent and refractory ITP patients, which is one of the problems that have attracted more attention and need to be solved urgently.
The main pathogenesis of ITP is the loss of platelet autoantigen immune tolerance, which leads to abnormal activation of humoral and cellular immunity. It is characterized by antibody mediated platelet destruction and insufficient platelet production by megakaryocytes. The residual long-term autoreactive plasma cells may be a source of therapeutic resistance to autoimmune cytopenia. Antiplatelet specific plasma cells have been detected in the spleen of patients with rituximab refractory ITP. Therefore, the strategy of simply eliminating B cells may not work, because LLPC will continue to produce pathogenic antibodies. In view of this, we expected that the combination of rituximab and anti-CD38 monoclonal antibody could simultaneously eliminate CD20 positive B cells and LLPC, thereby profoundly reducing the production of pathogenic antibodies and increasing the efficacy of ITP treatment. Some patients in our center have been treated with this regimen in the past, with good efficacy and safety. Therefore, we planned to conduct a clinical study to evaluate the safety and efficacy of rituximab combined with Daratumumab（anti-CD38 monoclonal antibody） in relapsed adult patients with primary immune thrombocytopenia, in order to provide more treatment options for patients with ITP.
- Conditions
- Immune Thrombocytopenia, Treatment
- Being tested
- Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody）
- 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.
Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody）Drug
For subjects in this study, rituximab (375mg/m2) was given once (day1) and Daratumumab（Anti-CD38 Monoclonal Antibody） (16mg/kg) was given eight times (day8,15,22,29,36,43,50,57).
| Study group | Role | What they receive |
|---|---|---|
| Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody） | Experimental | Rituximab (375mg/m2) was given once (day1) and a Daratumumab (16mg/kg) was given eight times (day8,15,22,29,36,43,50,57). Receives: Drug: Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody） |
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 either partial response or complete response at week 12. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 12 weeks
Secondary outcomes (12)
Response at each visit
Response at each visit was defined as either overall response, partial response, complete response or the proportion of subjects with a platelet counts ≥ 50×10^9/L and at least twice the baseline level at each visit. Overall response rate was defined as either partial response or complete response. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 1 year
Platelet counts at each visit
Platelet counts at each visit was defined as the platelet counts at each visit.
Measured: 1 year
Time to the first platelet counts ≥30×10^9/L
Time to the first platelet counts ≥30×10^9/L was defined as time to first platelet counts ≥30×10^9/L with at least doubling from baseline
Measured: 1 year
Time to the first platelet counts ≥50×10^9/L
Time to the first platelet counts ≥50×10^9/L was defined as time to first platelet counts ≥50×10^9/L with at least doubling from baseline
Measured: 1 year
Time to the first platelet counts ≥100×10^9/L
Time to the first platelet counts ≥100×10^9/L was defined as time to first platelet counts ≥100×10^9/L
Measured: 1 year
Cumulative durations of platelet counts ≥100×10^9/L, ≥50×10^9/L and ≥30×10^9/L, at least doubling from baseline
Cumulative durations of platelet counts≥100×10^9/L, ≥50×10^9/L and ≥30×10^9/L, at least doubling from baseline was defined as time from first two consecutive counts meeting criteria, to first two consecutive counts decreasing to below cut-off
Measured: 1 year
Proportion of subjects receiving rescue treatment
Proportion of patients receiving rescue drugs within 12 weeks and throughout the trial
Measured: 1 year
Concomitant treatment
Changes in concomitant treatment at week12 compared with that at baseline
Measured: 12 weeks
Changes in world health organization (WHO) bleeding scale
Changes in world health organization (WHO) bleeding scale without rescue treatment. Changes of every subject in WHO bleeding score after treatment according to the reported World Health Organization's Bleeding Scale. 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: 1 year
Overall response rate at week24
Overall response rate was defined as either partial response or complete response at week 24. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 24 weeks
Overall response rate at week52
Overall response rate was defined as either partial response or complete response at week 52. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 52 weeks
Adverse events assessment
Incidence, severity, and relationship of treatment emergent adverse events after treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362199
- Sponsor's protocol ID
- IIT2024069
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Phase II Clinical Study Evaluating the Efficacy of Rituximab Combined With Anti-CD38 Monoclonal Antibody in the Treatment of Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT07362199
- Acronym / sponsor ID
- IIT2024069
- Conditions
- Immune Thrombocytopenia, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined with Rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Detailed description
Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a considerable number of patients need drug maintenance treatment, which seriously affects the quality of life of patients and increases the economic burden of patients. Therefore, there is still a lack of effective treatment for adult ITP, especially for recurrent and refractory ITP patients, which is one of the problems that have attracted more attention and need to be solved urgently.
The main pathogenesis of ITP is the loss of platelet autoantigen immune tolerance, which leads to abnormal activation of humoral and cellular immunity. It is characterized by antibody mediated platelet destruction and insufficient platelet production by megakaryocytes. The residual long-term autoreactive plasma cells may be a source of therapeutic resistance to autoimmune cytopenia. Antiplatelet specific plasma cells have been detected in the spleen of patients with rituximab refractory ITP. Therefore, the strategy of simply eliminating B cells may not work, because LLPC will continue to produce pathogenic antibodies. In view of this, we expected that the combination of rituximab and anti-CD38 monoclonal antibody could simultaneously eliminate CD20 positive B cells and LLPC, thereby profoundly reducing the production of pathogenic antibodies and increasing the efficacy of ITP treatment. Some patients in our center have been treated with this regimen in the past, with good efficacy and safety. Therefore, we planned to conduct a clinical study to evaluate the safety and efficacy of rituximab combined with Daratumumab（anti-CD38 monoclonal antibody） in relapsed adult patients with primary immune thrombocytopenia, in order to provide more treatment options for patients with ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody） | Experimental | Drug: Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody）Rituximab (375mg/m2) was given once (day1) and a Daratumumab (16mg/kg) was given eight times (day8,15,22,29,36,43,50,57). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, male or female.
- Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.
- Subjects have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Subjects have failed at least one prior thrombopoietin receptor agonist therapy (such as rhTPO, eltrombopag, hetrombopag, etc.) in second-line treatment, as well as rituximab/anti-CD38 monoclonal antibody therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Alternatively, subjects have experienced treatment failure or post-splenectomy relapse following splenectomy.
- Subjects with a platelet count of <30×10^9/L within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) <30×10^9/L during the screening visit, and no platelet count > 35×10^9/L.
- ECOG performance status score of ≤2.
Key exclusion criteria (26 listed)
- Subjects allergic to CD20 monoclonal antibody or CD38 monoclonal antibody.
- Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.
- Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.
- Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.
- Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.
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 |
|---|---|---|
| Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody）For subjects in this study, rituximab (375mg/m2) was given once (day1) and Daratumumab（Anti-CD38 Monoclonal Antibody） (16mg/kg) was given eight times (day8,15,22,29,36,43,50,57). | Drug | Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody） |
Primary outcome
Overall response rate at week 12
Time frame: 12 weeks
Overall response rate was defined as either partial response or complete response at week 12. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
12 secondary outcomes
Response at each visit
Time frame: 1 year
Platelet counts at each visit
Time frame: 1 year
Time to the first platelet counts ≥30×10^9/L
Time frame: 1 year
Time to the first platelet counts ≥50×10^9/L
Time frame: 1 year
Time to the first platelet counts ≥100×10^9/L
Time frame: 1 year
Cumulative durations of platelet counts ≥100×10^9/L, ≥50×10^9/L and ≥30×10^9/L, at least doubling from baseline
Time frame: 1 year
Proportion of subjects receiving rescue treatment
Time frame: 1 year
Concomitant treatment
Time frame: 12 weeks
Changes in world health organization (WHO) bleeding scale
Time frame: 1 year
Overall response rate at week24
Time frame: 24 weeks
Overall response rate at week52
Time frame: 52 weeks
Adverse events assessment
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab combined with Daratumumab（Anti-CD38 Monoclonal Antibody） in people with Immune Thrombocytopenia and Treatment, 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 8 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 23 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang, MD (+8613502118379, zhanglei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate at week 12 (time frame: 12 weeks). 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 Jan 2026.