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Trial record 6 of 9 for:    MOR00208

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

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ClinicalTrials.gov Identifier: NCT04300803
Expanded Access Status : Available
First Posted : March 9, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
Clinigen Healthcare Ltd
Information provided by (Responsible Party):
MorphoSys AG

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
DLBCL 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.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
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)



Intervention Details:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300803


Contacts
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Contact: Clinigen Healthcare Ltd 1-877-768-4303 tafasitamab@clinigengroup.com

Sponsors and Collaborators
MorphoSys AG
Clinigen Healthcare Ltd
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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT04300803    
Other Study ID Numbers: MOR208N001
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Keywords provided by MorphoSys AG:
Tafasitamab
MOR00208
MOR208
monoclonal anti-CD19 antibody
Diffuse large B-cell lymphoma