Clinical Trials /

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Withdrawn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

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

  • ORG STUDY ID: MDV9300-01
  • NCT ID: NCT02653989

Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Primary Mediastinal Large B-cell Lymphoma
  • Transformed Indolent Lymphoma

Interventions

DrugSynonymsArms
MDV9300MDV9300

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.

Trial Arms

NameTypeDescriptionInterventions
MDV9300Experimental
  • MDV9300

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:

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Best overall response rate
Time Frame:no later than 6 months after the last patient is enrolled in a cohort
Safety Issue:
Description:Defined as the proportion of patients in the intent-to-treat population with a complete response (CR) or partial response (PR) attributable to study treatment, as assessed by the independent review committee (IRC).

Secondary Outcome Measures

Measure:Duration of response (for responders)
Time Frame:no later than 6 months after the last patient is enrolled in a cohort
Safety Issue:
Description:Defined as the time from the first objective evidence of CR or PR as assessed by the IRC to the first objective evidence of disease progression or death due to any cause, whichever occurs first.
Measure:Progression-free survival
Time Frame:no later than 6 months after the last patient is enrolled in a cohort
Safety Issue:
Description:Defined as the time from the date of first study drug infusion to the first objective evidence of disease progression or death due to any cause, whichever occurs first.
Measure:Time to response (for responders)
Time Frame:no later than 6 months after the last patient is enrolled in a cohort
Safety Issue:
Description:Defined as the time from the date of first study drug infusion to the first objective evidence of CR or PR as assessed by the IRC.
Measure:Overall survival
Time Frame:no later than 6 months after the last patient is enrolled in a cohort
Safety Issue:
Description:Defined as the time from the date of first study drug infusion to death due to any cause.
Measure:Composite of safety
Time Frame:no later than 6 months after the last patient is enrolled in a cohort
Safety Issue:
Description:Safety will be evaluated by incidence and severity of adverse events, including serious adverse events and incidence of permanent treatment discontinuation due to adverse events.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Withdrawn
Lead Sponsor:Medivation, Inc.

Last Updated

November 25, 2016