Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Medivation

Status and phase

Withdrawn

Phase 2

Conditions

Transformed Indolent Lymphoma

Lymphoma, Large B-Cell, Diffuse

Primary Mediastinal Large B-cell Lymphoma

Treatments

Biological: MDV9300

Study type

Interventional

Funder types

Industry

Identifiers

NCT02653989

MDV9300-01

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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