CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Moxetumomab pasudotox +1 moredrug
Likely dose
Not stated in 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/NCT01829711
NCT01829711Phase 3Completed
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A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia

MedImmune LLC·interventional·Posted Apr 11, 2013·Updated Apr 8, 2020

In Brief

A Phase 3 clinical trial evaluating Moxetumomab pasudotox and IV Bag Protectant for Moxetumomab pasudotox for Leukemia, Hairy Cell. Completed, enrolled 80 participants across 34 sites in 14 countries.

Detailed Summary

Background: \- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Hairy Cell
CountriesBelgium, Canada, Czechia, France, Germany, Ireland, Israel, Italy, Norway, Poland, Serbia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2013
Enrollment StartApr 29, 2013
Primary CompletionMay 24, 2017
Study CompletionApr 29, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.2 years ago

Interventions

Moxetumomab pasudotoxdrug

IV Bag Protectant for Moxetumomab pasudotoxdrug