Official Title
Expanded Access Program to Provide Tafasitamab in Combination With Lenalidomide to Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma Who Are Refractory to at Least One Anti-CD20 Antibody Containing Treatment Regimen
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. This program will require company, IRB/IEC and relevant IND approval .

Available
Individual Patients
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
Expanded Access Program, Non-Interventional Study

Eligibility Criteria

Major Inclusion Criteria :

1. Age ≥ 18 years

2. Histologically-confirmed diagnosis of DLBCL, including transformation from an earlier diagnosis of indolent lymphoma

3. Patients must have relapsed and/or refractory DLBCL, including primary refractory disease and double/triple hit status, after at least one prior anti-CD20 containing regimen.

4. 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 NHL, PMBL or Burkitt Lymphoma

2. Patients who have had, within 14 days prior to Day 1 dosing: - undergone major surgery or suffered from significant traumatic injury - received live vaccines

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Contacts

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

MorphoSys AG
Clinigen Healthcare Ltd
NCT Number
Keywords
Tafasitamab
MOR00208
MOR208
monoclonal anti-CD19 antibody
Diffuse Large b-cell Lymphoma
MeSH Terms
Antibodies