Trials / Withdrawn
WithdrawnNCT02653989
Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
An International, Phase 2, Open-Label, Efficacy and Safety Study of MDV9300 in Patients With an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B-Cell Lymphoma
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Medivation, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy. Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.
Conditions
- Lymphoma, Large B-Cell, Diffuse
- Primary Mediastinal Large B-cell Lymphoma
- Transformed Indolent Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MDV9300 | MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-06-01
- Completion
- 2018-08-01
- First posted
- 2016-01-13
- Last updated
- 2016-11-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02653989. Inclusion in this directory is not an endorsement.