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 (firstname.lastname@example.org).
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. This program will require company, IRB/IEC and relevant IND approval .
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. Histologically-confirmed diagnosis of DLBCL, including transformation from an earlier diagnosis of indolent lymphoma
3. Patients must have relapsed and/or refractory DLBCL, including primary refractory disease and double/triple hit status, after at least one prior anti-CD20 containing regimen.
4. 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 NHL, PMBL or Burkitt Lymphoma
2. Patients who have had, within 14 days prior to Day 1 dosing: - undergone major surgery or suffered from significant traumatic injury - received live vaccines
Clinigen Healthcare Ltd