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A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia

NCT00587457 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-07-06

Study results available
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Summary

This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic Lymphoma (SLL).

Conditions

  • Leukemia, Lymphoma, Chronic Lymphocytic
  • Leukemia, Prolymphocytic Leukemia, Small
  • Lymphocytic Lymphoma, Moxetumomab Pasudotox

Interventions

DRUG

CAT-8015 5 mcg/kg

Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

DRUG

CAT-8015 10 mcg/kg

Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

DRUG

CAT-8015 20 mcg/kg

Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Sponsors & Collaborators

  • Cambridge Antibody Technology

    collaborator OTHER

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Mark C Lanasa, M.D.,Ph.D · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-07
Primary Completion
2008-04-07
Completion
2008-04-07

Countries

  • United States
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00587457 on ClinicalTrials.gov