Status:
APPROVED_FOR_MARKETING
Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL
Lead Sponsor:
MorphoSys AG
Collaborating Sponsors:
Clinigen Healthcare Ltd
Conditions:
DLBCL
Eligibility:
All Genders
18+ years
Brief Summary
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 th...
Detailed Description
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 doubl...
Eligibility Criteria
Inclusion
- Major Inclusion Criteria :
- Age ≥ 18 years
- Patient able to provide written informed consent
- Histologically-confirmed diagnosis of DLBCL, including transformation from an earlier diagnosis of indolent lymphoma.
- 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.
- 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:
- 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:
- Known active bacterial and viral and fungal infections
- Serology of chronic active viral Hepatitis B and/or C-Hepatitis
- Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
- Patients who are unable to participate in the lenalidomide REMS program
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04300803
Last Update
August 28 2020
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