NCT04300803

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).

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
Last Updated

August 28, 2020

Status Verified

May 1, 2020

First QC Date

March 5, 2020

Last Update Submit

August 26, 2020

Conditions

DLBCL

Keywords

TafasitamabMOR00208MOR208monoclonal anti-CD19 antibodyDiffuse large B-cell lymphoma

Interventions

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 progressionBIOLOGICAL

Expanded Access Program, Non-Interventional Study

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

tafasitamab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 9, 2020

Last Updated

August 28, 2020

Record last verified: 2020-05