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Trial record 6 of 18 for:    MOR00208

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

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ClinicalTrials.gov Identifier: NCT04300803
Expanded Access Status : Approved for marketing
First Posted : March 9, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborator:
Clinigen Healthcare Ltd
Information provided by (Responsible Party):
MorphoSys AG

Tracking Information
First Submitted Date March 5, 2020
First Posted Date March 9, 2020
Last Update Posted Date August 28, 2020
 
Descriptive Information
Brief Title Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL
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 Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04300803
Responsible Party MorphoSys AG
Study Sponsor MorphoSys AG
Collaborators Clinigen Healthcare Ltd
Investigators Not Provided
PRS Account MorphoSys AG
Verification Date May 2020