Immune Thrombocytopenia Clinical Trial
Official title:
A Investigator-initiated Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Relapsed/Refractory Primary Immune Thrombocytopenia
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institute of Hematology & Blood Diseases Hospital |
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 |
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)
|