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

Primary Purpose

Immune Thrombocytopenia

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Daratumumab Injection
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged ≥18 years.
  • Diagnosed with ITP that has persisted for ≥3 months and with a platelet count of <30 X 109/L measured within 2 days prior to inclusion.
  • Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab.
  • If receiving emergency care for ITP, treatment should be stopped >2 weeks before first dose.
  • A positive result to the ELISA test to detect antibody against GPIIb/IIIa or GPIIb/IIIa and GPIb/IX within 1 week prior to inclusion.
  • With normal hepatic and renal functions.
  • ECOG Performance Status ≤ 2.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Daratumumab once a week x 8 doses

    Outcomes

    Primary Outcome Measures

    Evaluate of response after daratumumab treatment
    Response defined as platelet count ≥50 x109/L .8 weeks after the first dose.
    Safety of daratumumab
    Incidence of treatment emergent adverse events after daratumumab treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2022
    Last Updated
    September 28, 2022
    Sponsor
    Institute of Hematology & Blood Diseases Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05562882
    Brief Title
    A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia
    Official Title
    A Investigator-initiated Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Relapsed/Refractory Primary Immune Thrombocytopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Hematology & Blood Diseases Hospital, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    A single-center, open-label, off-label use investigator-initiated clinical study with safety run-in 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.
    Detailed Description
    Primary immune thrombocytopenia is an autoimmune disease associated with a reduced peripheral blood platelet count. The first-line treatment is corticosteroids. Splenectomy, rituximab, and thrombopoietin receptor agonists (TPO RAs, such as Etrapopar and Romistine) are commonly used as second-line therapy. However, many of the treatments used achieve few lasting remissions. About 20% - 30% of patients have inadequate or no response to first-line and second-line treatment, and would develop into recurrent/refractory (r/r) ITP. A branch of pathogenesis for ITP has been revealed that plasma cells secrete pathogenic antibodies directed against platelet and red blood cell antigens. Antiplatelet specific plasma cells have been detected in the spleen of patients with rituximab refractory ITP. In those refractory cases, persistent autoreactive long-lived plasma cells in the bone marrow could explain treatment failure. Daratumumab, an anti-CD38 monoclonal antibody developed to target tumoral plasma cells in multiple myeloma, was recently found to be effective in antibody-mediated diseases, such as autoimmune cytopenia following hematopoietic stem cell transplantation, systemic lupus and also ITP. This study will evaluate the safety and biologic activity of Daratumumab in r/r primary ITP who fail to respond to at least one previous second-line therapy. The study will enroll approximately 20 participants. This trial will be conducted in China. All participants will be followed for at least 16 weeks after the 8 weeks of treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immune Thrombocytopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Daratumumab once a week x 8 doses
    Intervention Type
    Drug
    Intervention Name(s)
    Daratumumab Injection
    Other Intervention Name(s)
    Darzalex
    Intervention Description
    intravenous daratumumab administration
    Primary Outcome Measure Information:
    Title
    Evaluate of response after daratumumab treatment
    Description
    Response defined as platelet count ≥50 x109/L .8 weeks after the first dose.
    Time Frame
    9-24 weeks
    Title
    Safety of daratumumab
    Description
    Incidence of treatment emergent adverse events after daratumumab treatment
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female aged ≥18 years. Diagnosed with ITP that has persisted for ≥3 months and with a platelet count of <30 X 109/L measured within 2 days prior to inclusion. Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab. If receiving emergency care for ITP, treatment should be stopped >2 weeks before first dose. A positive result to the ELISA test to detect antibody against GPIIb/IIIa or GPIIb/IIIa and GPIb/IX within 1 week prior to inclusion. With normal hepatic and renal functions. ECOG Performance Status ≤ 2. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lei Zhang, M.D.
    Phone
    +86 022-23909083
    Email
    zhanglei1@ihcams.ac.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lei Zhang, M.D.
    Organizational Affiliation
    Institute of Hematology & Blood Diseases Hospital, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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