Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05562882
Other study ID # IIT2022039-EC-1
Secondary ID 2022-D-ITP
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date October 15, 2022
Est. completion date May 31, 2024

Study information

Verified date September 2022
Source Institute of Hematology & Blood Diseases Hospital
Contact Lei Zhang, M.D.
Phone +86 022-23909083
Email zhanglei1@ihcams.ac.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date May 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Daratumumab Injection
intravenous daratumumab administration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate of response after daratumumab treatment Response defined as platelet count =50 x109/L .8 weeks after the first dose. 9-24 weeks
Primary Safety of daratumumab Incidence of treatment emergent adverse events after daratumumab treatment 24 weeks
See also
  Status Clinical Trial Phase
Completed NCT02287649 - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP) N/A
Completed NCT02556814 - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP Phase 4
Completed NCT02868099 - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Phase 3
Terminated NCT02401061 - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP Phase 1/Phase 2
Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
Active, not recruiting NCT04741139 - Post IVIG Medication in Children With Immune Thrombocytopenia Phase 1
Not yet recruiting NCT05494307 - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
Recruiting NCT04993885 - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2
Recruiting NCT05281068 - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05020288 - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP Phase 2
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Not yet recruiting NCT03252457 - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP Phase 3
Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed NCT03156452 - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate Phase 3
Completed NCT03164915 - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT02270801 - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy Phase 3
Withdrawn NCT01976195 - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP Phase 2
Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
Recruiting NCT02821572 - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)