CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
CAT-8015 (Moxetumomab Pasudotox) +9 moredrug
Likely dose
CAT-8015 (Moxetumomab Pasudotox) 5 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/NCT00659425
NCT00659425Phase 1Completed
CompareCT.gov

A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Children, Adolescents and Young Adults With Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL)

MedImmune LLC·interventional·Posted Apr 16, 2008·Updated Oct 2, 2017

In Brief

A Phase 1 clinical trial evaluating CAT-8015 (Moxetumomab Pasudotox) for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. Completed, enrolled 57 participants across 5 sites in 2 countries.

Detailed Summary

A dose-escalation study to estimate maximum cummulative dose (MTCD) of CAT-8015 that can be safely administered to a participant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 16, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 18.2 years ago

Interventions

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.

CAT-8015 (Moxetumomab Pasudotox)drug

Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.