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.
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
Drug | Synonyms | Arms |
---|
MDV9300 | | MDV9300 |
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
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:
- 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