Back to resultsEfficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Primary Purpose
Lymphoma, Large B-Cell, Diffuse, Primary Mediastinal Large B-cell Lymphoma, Transformed Indolent Lymphoma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MDV9300
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MDV9300
Arm Description
Outcomes
Primary Outcome Measures
Best overall response rate
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
Duration of response (for responders)
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.
Progression-free survival
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.
Time to response (for responders)
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.
Overall survival
Defined as the time from the date of first study drug infusion to death due to any cause.
Composite of safety
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02653989
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Primary Mediastinal Large B-cell Lymphoma, Transformed Indolent Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDV9300
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MDV9300
Intervention Description
MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.
Primary Outcome Measure Information:
Title
Best overall response rate
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).
Time Frame
no later than 6 months after the last patient is enrolled in a cohort
Secondary Outcome Measure Information:
Title
Duration of response (for responders)
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.
Time Frame
no later than 6 months after the last patient is enrolled in a cohort
Title
Progression-free survival
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.
Time Frame
no later than 6 months after the last patient is enrolled in a cohort
Title
Time to response (for responders)
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.
Time Frame
no later than 6 months after the last patient is enrolled in a cohort
Title
Overall survival
Description
Defined as the time from the date of first study drug infusion to death due to any cause.
Time Frame
no later than 6 months after the last patient is enrolled in a cohort
Title
Composite of safety
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.
Time Frame
no later than 6 months after the last patient is enrolled in a cohort
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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