Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

NCT07234019 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2023053
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, open-label study aim to compare the efficacy and safety of rituximab combining anti-CD38 monoclonal antibody 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.

Conditions

Treatment; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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 TPO-RA or corticosteroids during the study period.

  12 weeks

Secondary Outcomes (12)

• Complete remission rate at week 12

  12 weeks

• Partial remission rate at week 12

  12 weeks

• Overall response rate at month 6

  6 months

• Overall response rate at month 12

  12 months

• Sustained response rate at month 6

  6 months

Study Arms (2)

rituximab combined with Daratumumab（anti-CD38 monoclonal antibody）

EXPERIMENTAL

Rituximab (375mg/m2) was given once (day1) and a Daratumumab (16mg/kg) was given four times (day8,15,22,29).

Drug: Daratumumab（Anti-CD38 Monoclonal Antibody）; Drug: Rituximab

rituximab

ACTIVE COMPARATOR

Rituximab (375mg/m2) was given once.

Drug: Rituximab

Interventions

Rituximab DRUG

All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group A (active comparator) , rituximab (375mg/m2) was given once. For subjects in group B (experimental), rituximab (375mg/m2) was given once (day1) and anti-CD38 monoclonal antibody (16mg/kg) was given four times (day8,15,22,29).

rituximab; rituximab combined with Daratumumab（anti-CD38 monoclonal antibody）

Daratumumab（Anti-CD38 Monoclonal Antibody） DRUG

All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group B (experimental), rituximab (375mg/m2) was given once (day1) and Daratumumab (16mg/kg) was given four times (day8,15,22,29).

rituximab combined with Daratumumab（anti-CD38 monoclonal antibody）

Eligibility Criteria

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

You may qualify if:

• 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 with a platelet count of \<30×10\^9/L within the 48 hours prior to the first dose of the study drug;The platelet count of at least two separate assessments (at least 1 week apart) \<30×10\^9/L during the screening visit.
• Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse).
• Previous emergency treatment for ITP (e.g., methylprednisolone, platelet, gamma globulin infusion) must have been completed at least 2 weeks before the first dose.
• Hepatic and renal function (e.g., alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatinine) \<1.5 times the upper limit of normal (ULN).
• ECOG performance status score of ≤2.
• Cardiac function: New York Heart Association (NYHA) class ≤2.
• Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists, but the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug; Azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first dose; CD20 monoclonal antibody such as rituximab must have been stopped for more than 6 months; the interval between splenectomy and first administration need to be more than 6 months.
• 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 90 days 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.

You may not qualify if:

• Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases.
• HIV positive.
• Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive.
• Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc..
• At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled.
• Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis.
• Those who have received allogeneic stem cell transplantation or organ transplantation in the past.
• atients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up.
• Patients whose toxic symptoms caused by pre-trial treatment have not disappeared.
• Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.).
• Patients with septicemia or other irregular severe bleeding.
• Patients taking antiplatelet drugs at the same time.
• Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.
• Subjects with a known allergy to medications were used in the trial or excipients.
• Any other conditions unsuitable for participation in this study, as assessed by the investigator.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; 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

Central Study Contacts

Lei Zhang, MD

CONTACT

+8613502118379; zhanglei1@ihcams.ac.cn

Yunfei Chen, MD

CONTACT

+8618502220788; chenyunfei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months to 36 months after study completion
• Access Criteria: Upon request to PI

Locations

CN (1)