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

Sponsor
MorphoSys AG (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT04300803
Collaborator
Clinigen Healthcare Ltd (Other)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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

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 Design

Study Type:
Expanded Access
Official Title:
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)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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:

    4. Known active bacterial and viral and fungal infections

    5. Serology of chronic active viral Hepatitis B and/or C-Hepatitis

    6. Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)

    7. Patients who are unable to participate in the lenalidomide REMS program

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • MorphoSys AG
    • Clinigen Healthcare Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MorphoSys AG
    ClinicalTrials.gov Identifier:
    NCT04300803
    Other Study ID Numbers:
    • MOR208N001
    First Posted:
    Mar 9, 2020
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    May 1, 2020
    Keywords provided by MorphoSys AG
    Tafasitamab
    MOR00208
    MOR208
    monoclonal anti-CD19 antibody
    Diffuse large B-cell lymphoma

    Study Results

    No Results Posted as of Aug 28, 2020