Immune Thrombocytopenia Clinical Trial
Official title:
A Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune Cytopenia
Some patients with antibody-mediated autoimmune hematological diseases (warm autoimmune
hemolytic anemia (wAIHA), cold agglutinin disease (cAIHA) and immune thrombocytopenia (ITP))
shows no or only minor and transient response to therapy despite several treatment-lines.
Such patients are more likely to have a severe disease, with a higher morbidity and
mortality.
Hypothesis Effective depletion of autoreactive plasma cells might be the key for a curative
approach of these diseases. Therefore, there is a rationale for using proteasome inhibitors
(PIs) in these refractory patients.
The rationale is that non-tumoral autoreactive plasma cells are rapidly targeted by
proteasome inhibitors. It led us to propose a short course of dexamethasone and ixazomib (5
cycles), to evaluate the safety/efficacy of this innovative strategy of treatment.
Method Prospective interventional uncontrolled single arm open study evaluating the rate of
patients achieving 5 cycles of ixazomib and dexamethasone without severe toxicity and
response on therapy.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02287649 -
Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)
|
N/A | |
| Terminated |
NCT02401061 -
PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP
|
Phase 1/Phase 2 | |
| Completed |
NCT02868099 -
Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
|
Phase 3 | |
| Completed |
NCT02556814 -
Caffeic Acid Combining High-dose Dexamethasone in Management of ITP
|
Phase 4 | |
| 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 |
NCT05468866 -
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
|
N/A | |
| Not yet recruiting |
NCT05494307 -
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
| Recruiting |
NCT05281068 -
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
| Recruiting |
NCT04993885 -
Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
|
Phase 2 | |
| Not yet recruiting |
NCT05020288 -
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
|
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)
|
||
| Not yet recruiting |
NCT05562882 -
A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia
|
Early Phase 1 |