Expanded Access Program (EAP) to provide Tafasitamab (MOR208) to eligible patients withrelapsed or refractory Diffuse Large B Cell Lymphoma. Access to MorphoSys´ EAP can berequested 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.
Biological: 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
Expanded Access Program, Non-Interventional Study
Major Inclusion Criteria :
1. Age ≥ 18 years
2. Patient able to provide written informed consent
3. Histologically-confirmed diagnosis of DLBCL, including transformation from an
earlier diagnosis of indolent lymphoma.
4. Patients must have relapsed and/or refractory DLBCL, including primary refractory
disease and double/triple hit status, after at least 1 prior anti-CD20 containing
regimen.
5. Patients with a serious, life-threatening illness in which conventional therapies
have failed, are unsuitable and/or are unavailable and participation in ongoing
relevant clinical trials is not feasible.
Major Exclusion Criteria:
1. Patients who have other histological type of lymphoma, e.g. indolent Non-Hodgkin
lymphoma (NHL), Primary mediastinal B-cell lymphoma (PMBL) or Burkitt Lymphoma
2. Patients who are not willing/able to take venous thromboembolic event prophylaxis
during the entire treatment period with lenalidomide
3. Patients with:
1. Known active bacterial and viral and fungal infections
2. Serology of chronic active viral Hepatitis B and/or C-Hepatitis
3. Known seropositivity for or history of active viral infection with human
immunodeficiency virus (HIV)
4. Patients who are unable to participate in the lenalidomide REMS program