Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | August 2018 |
| Contact: | Medivation Clinical Operations |
| Email: | MDV9300-01@medivation.com |
| Phone: | +1 (415) 543-3470 |
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
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of serious autoimmune disease;
- History of central nervous system involvement of lymphoma;
- Prior therapy with agents targeting immune coinhibitory receptors.
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