Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Withdrawn before enrolling · Phase 2
Conditions studied: Lymphoma, Large B-Cell, Diffuse, Primary Mediastinal Large B-cell Lymphoma, Transformed Indolent Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02653989
- Run by
- Medivation, Inc.
- People needed
- 0
- Starts
- 2016-12-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2016-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older and willing and able to provide informed consent;
- Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;
- Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;
- For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;
- For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT just prior to MDV9300 treatment must have resulted in a PR or stable disease;
- Adequate bone marrow reserve as defined per protocol;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Patients with stable ECOG scores of 2 may be allowed with medical monitor approval.
You may not qualify if…
- Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma
- History of serious autoimmune disease;
- History of central nervous system involvement of lymphoma;
- Prior therapy with agents targeting immune coinhibitory receptors.
Where it is running
- Study site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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