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

An Expanded Access Protocol to Provide Intermediate Access to Tafasitamab (MOR208) for the Combination Treatment With Lenalidomide to Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04300803
Enrollment
Unknown
Registered
2020-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DLBCL

Keywords

Tafasitamab, MOR00208, MOR208, monoclonal anti-CD19 antibody, Diffuse large B-cell lymphoma

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.

Interventions

BIOLOGICALTafasitamab, 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

Sponsors

Clinigen Healthcare Ltd
CollaboratorUNKNOWN
MorphoSys AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026