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

August 26, 2020 updated by: MorphoSys AG

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)

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).

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MorphoSys AG

Collaborators

Clinigen Healthcare Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MOR208N001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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