Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
NCT ID: NCT02653989
Last Updated: 2016-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-12-31
2018-08-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MDV9300
MDV9300
MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.
Interventions
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MDV9300
MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Medivation, Inc.
INDUSTRY
Responsible Party
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Locations
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Nashville, Tennessee, United States
Countries
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Other Identifiers
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MDV9300-01
Identifier Type: -
Identifier Source: org_study_id