A Phase I, Multicenter dose escalation study in patients with hairy cell leukemia

Study identifier:CAT-8015-1001

ClinicalTrials.gov identifier:NCT00586924

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients with Relapsed or Refractory Hairy Cell Leukemia (HCL)

Medical condition

Hairy cell leukemia

Phase

Phase 1

Healthy volunteers

No

Study drug

Moxetumomab Pasudotox (CAT 8015), Moxetumomab Pasudotox (CAT 8015), Moxetumomab Pasudotox (CAT 8015), Moxetumomab Pasudotox (CAT 8015), CAT 8015 (Moxetumomab Pasudotox), Moxetumomab Pasudotox (CAT 8015)

Sex

All

Actual enrollment

49

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 10 May 2007
Primary Completion Date: 06 May 2015
Study Completion Date: 06 May 2015

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2018 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

Cambridge Antibody Technology

Inclusion and exclusion criteria