CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

Summary

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

Conditions

• Acute Lymphoblastic Leukemia
• Non-Hodgkin's Lymphoma

Interventions

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

DRUG

CAT-8015 (Moxetumomab Pasudotox)

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• MedImmune LLC

  lead INDUSTRY

Principal Investigators

• Medimmune LLC Medimmune LLC · MedImmune LLC

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Months

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• United States
• Canada

Study Locations