A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia

NCT05562882 | Active Not Recruiting Phase 2

• 2 other identifiers: IIT2022039（1）2022-D-ITP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, open-label, off-label use investigator-initiated clinical study to explore the clinical activity and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• Evaluate of response after daratumumab treatment

  The proportion of patients with 2 consecutive platelet counts of ≥ 50×109/L within 8 weeks

  8 weeks

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of daratumumab

  Incidence, severity, and relationship of treatment emergent adverse events after daratumumab treatment

  24 weeks

Secondary Outcomes (10)

• The proportion of patients with ≥2 consecutive platelet counts (separated by ≥7 days) of ≥30 × 109/L and a ≥2-fold increase from the baseline count within 8 weeks

  8 weeks

• Time to first platelet count of ≥50 × 109/L without salvage therapy.

  24 weeks

• Overall response rate at week 8 and week 24

  24 weeks

• Complete response rate at week 8 and week 24

  24 weeks

• Cumulative response duration of platelet count of ≥30 × 109/L and a platelet count doubling from the baseline within 24 weeks

  24 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Daratumumab once a week x 8 doses

Drug: Daratumumab Injection

Interventions

Daratumumab Injection DRUG

intravenous daratumumab administration

Also known as: Darzalex

Intervention

Eligibility Criteria

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

You may qualify if:

• Male or female aged ≥18 years.
• Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab and/or TPO-RA.
• If receiving emergency care for ITP, treatment should be stopped \>2 weeks before first dose.
• With normal hepatic and renal functions.
• ECOG Performance Status ≤ 2.
• February 16, 2023 After approval by the Ethics Committee on , subjects no longer require platelet glycoprotein autoantibodies positivity upon enrollment.

You may not qualify if:

• Received any treatment of anti-CD38 antibody drug.
• Has been diagnosed with malignancy and/or liver failure, heart failure and renal failure.
• Known previous infection or seropositivity for HIV, Hepatitis B, Hepatitis C, Cytomegalovirus, EB virus, Syphilis.
• Any clinically overt hemorrhage.
• Has been diagnosed with cardiac disease, arrhythmia and/or severe or uncontrollable hypertension
• Known pulmonary embolism, thrombosis and/or atherosclerosis.
• Has been received allogeneic stem cell transplantation or organ transplantation.
• Patients with history of current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
• Pregnancy or lactation.

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

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

daratumumab

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

Study Officials

• Lei Zhang, M.D.

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: December 10, 2022
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2024-05

Locations

CN (1)