Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL

• Conditions: DLBCL

• Registration Number: NCT04300803
• Lead Sponsor: MorphoSys AG

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 the respective CRO Clinigen (tafasitamab@clinigengroup.com).

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 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.

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified