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| Name | Class |
|---|---|
| Clinigen Healthcare Ltd | UNKNOWN |
Expanded Access Program (EAP) to provide Tafasitamab (MOR208) to eligible patients with relapsed or refractory Diffuse Large B Cell Lymphoma. Access to MorphoSys´ EAP can be requested by contacting the respective CRO Clinigen (tafasitamab@clinigengroup.com).
This program is intended to provide access to patients with relapsed and/or refractory DLBCL who had at least one prior anti-CD20 containing regimen. Patients with primary refractory disease and double/triple hit status are also eligible. Patients considering this access program should have no other therapeutic option, and are not eligible for other clinical trials. The expanded access program (MOR208N001) is currently available in the United States only.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafasitamab, 12 mg/kg. 4 week cycles: weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), loading dose Cycle 1, day 4. Cycle 4 onwards day 1, day 15 until disease progression | Biological | Expanded Access Program, Non-Interventional Study |
Major Inclusion Criteria :
Major Exclusion Criteria:
Patients who have other histological type of lymphoma, e.g. indolent Non-Hodgkin lymphoma (NHL), Primary mediastinal B-cell lymphoma (PMBL) or Burkitt Lymphoma
Patients who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period with lenalidomide
Patients with:
Patients who are unable to participate in the lenalidomide REMS program
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000613469 | tafasitamab |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |