A Phase 2 interventional study of MDV9300 in Lymphoma, Large B-Cell, Diffuse, Primary Mediastinal Large B-cell Lymphoma and Transformed Indolent Lymphoma, sponsored by Medivation, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-25.
Sponsored by Medivation, Inc. · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
Browse Lymphoma studies →Medivation, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: MDV9300
MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.
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).
Time frame: no later than 6 months after the last patient is enrolled in a cohort
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.
Time frame: no later than 6 months after the last patient is enrolled in a cohort
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 frame: no later than 6 months after the last patient is enrolled in a cohort
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.
Time frame: no later than 6 months after the last patient is enrolled in a cohort
Overall survival
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
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.
Time frame: no later than 6 months after the last patient is enrolled in a cohort
This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Medivation, Inc.