Trials / Completed
CompletedNCT01685008
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)
A Phase IIa, Open-label, Multicenter Study of Single-agent MOR00208, an Fc-optimized Anti-CD19 Antibody, in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- MorphoSys AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter study to characterize the safety and efficacy of the human anti-CD19 antibody MOR00208 in adult patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) who have received at least 1 prior therapy containing rituximab (at least once).
Detailed description
The study enrols patients from four different NHL subtypes: follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other indolent NHL (iNHL). The study will employ a two-stage design where the decision to further enrol any NHL subtype in stage 2 will depend on best responses after two or three cycles in stage 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MOR00208 (formerly Xmab 5574) |
Timeline
- Start date
- 2013-04-23
- Primary completion
- 2022-04-06
- Completion
- 2022-04-06
- First posted
- 2012-09-13
- Last updated
- 2023-11-07
- Results posted
- 2023-11-07
Locations
22 sites across 7 countries: United States, Belgium, Germany, Hungary, Italy, Poland, Spain
Source: ClinicalTrials.gov record NCT01685008. Inclusion in this directory is not an endorsement.