Clinical trial · Expanded Access

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

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)

NCT04300803CI-TRIAL-00046845approved for marketingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
DLBCL	Diffuse Large B-Cell Lymphoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
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	Biological	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.