CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Imexondrug
Likely dose
Imexon 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01314014
NCT01314014Phase 2Completed
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A Phase II Study of Amplimexon® (Imexon for Injection) for the Treatment of Previously Treated Follicular and Aggressive Lymphoma in Adults

University of Rochester·interventional·Posted Mar 14, 2011·Updated Jan 6, 2016

In Brief

A Phase 2 clinical trial evaluating Imexon for Follicular Lymphoma and 6 related conditions. Completed, enrolled 22 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine whether Amplimexon (imexon for injection) is effective in the treatment of indolent and aggressive lymphomas that have progressed after treatment with standard therapies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Burkitt's Lymphoma
CountriesUnited States
CollaboratorsUniversity of Arizona

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartMay 1, 2011
Primary CompletionMar 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.3 years ago

Interventions

Imexondrug

Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.