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

NCT02653989

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory <span class="go-doc-concept go-doc-disease">Diffuse Large B-cell Lymphoma (DLBCL)</span>

Title

  • Brief Title: Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
  • Official Title: 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
  • Clinical Trial IDs

    NCT ID: NCT02653989

    ORG ID: MDV9300-01

    Trial Conditions

    Lymphoma, Large B-Cell, Diffuse

    Primary Mediastinal Large B-cell Lymphoma

    Transformed Indolent Lymphoma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    MDV9300 Experimental

    Eligibility Criteria

    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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Best overall response rate

    Secondary Outcome Measures

    Duration of response (for responders)

    Progression-free survival

    Time to response (for responders)

    Overall survival

    Composite of safety

    Trial Keywords