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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525728-18-00 | EU Trial (CTIS) Number |
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The goal of this clinical trial is to investigate the safety of rituximab for management of immune-related adverse events in malignant melanoma patients. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab (RTX) | Drug | A single ultra-low dose rituximab (100 mg) infusion for patients with immune-related adverse events |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of rituximab-related adverse events graded according to CTCAE v. 6.0 | Safety of rituximab is evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) v. 6.0 and include the incidence and severity of rituximab-related adverse events until 6 months post treatment. | Until 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Immune-related adverse event management response | The immune-related adverse events management response, defined as number of days until symptom control (corresponding to CTCAE grade 0-1 of the immune-related adverse event) | Until 6 months post treatment |
| Corticosteroid dependency |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in circulating B cells | Changes in circulating B cells/B cell depletion will be evaluated by assessing changes in CD19+ and/or CD20+ B cell counts from baseline to 16 weeks post treatment. | Until 16 weeks post treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inge Marie Svane, Professor, MD, PhD | Contact | 004538683868 | inge.marie.svane@regionh.dk | |
| Frederikke Strauss Hansen, MD, PhD-student | Contact | 004538683868 | frederikke.strauss.hansen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital | Herlev | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Corticosteroid dependency in rituximab treated patients measured as the number of days on corticosteroids following rituximab infusion. |
| Until 6 months post treatment |
| Dose of corticosteroids | Assessment of rituximab efficacy measured as cumulative dose and peak dose of corticosteroids. | Until 6 months post treatment |
| Second- or third-line immunosuppressants | Assessment of rituximab efficacy measured as the proportion of patients requiring second- or third-line immunosuppressive therapy after rituximab | Until 6 months post treatment |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |