Trials / Completed
CompletedNCT02399085
Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- MorphoSys AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).
Detailed description
The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who had relapsed after or were refractory to at least one, but no more than three previous systemic regimens administered for the treatment of their DLBCL and who were not candidates for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus considered to have exhausted their therapeutic options. One prior therapy line had to include an anti-CD20 targeted therapy (e.g., rituximab \[RTX\]). MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208 monotherapy until progression, in participants with at least stable disease or a better response.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tafasitamab | 12 mg/kg |
| DRUG | Lenalidomide | 25 mg |
Timeline
- Start date
- 2016-03-29
- Primary completion
- 2022-11-14
- Completion
- 2023-04-19
- First posted
- 2015-03-26
- Last updated
- 2023-10-23
- Results posted
- 2020-02-05
Locations
57 sites across 10 countries: United States, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02399085. Inclusion in this directory is not an endorsement.