CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
CAT-8015 20 mcg/kg +4 moredrug
Likely dose
CAT-8015 20 mcg/kgfrom 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/NCT01030536
NCT01030536Phase 2Completed
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A Phase 1/2 Study of CAT-8015 in Adult Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

MedImmune LLC·interventional·Posted Dec 11, 2009·Updated Apr 9, 2018

In Brief

A Phase 2 clinical trial evaluating CAT-8015 20 mcg/kg, CAT-8015 30 mcg/kg, and 3 other interventions for Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. Completed, enrolled 23 participants across 8 sites in 2 countries.

Detailed Summary

The primary objectives of this study are to determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], mantle cell lymphoma \[MCL\]) or CLL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
CountriesPoland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2009
Enrollment StartFeb 15, 2010
Primary CompletionMar 4, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.6 years ago

Interventions

CAT-8015 20 mcg/kgdrug

Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.

CAT-8015 30 mcg/kgdrug

Participants will receive 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.

CAT-8015 40 mcg/kgdrug

Participants will receive 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.

CAT-8015 50 mcg/kgdrug

Participants will receive 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.

CAT-8015 60 mcg/kgdrug

Participants will receive 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.