Clinical Trial: A Phase I, Multicenter Dose Escalation Study in Patients With Leukemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: To administer the highest dose that can safely be given to a patient and establish the safest dose based on the highest tolerated dose for clinical testing.

Detailed Summary: To estimate the maximum tolerated dose (MTD), defined as the highest dose that can be safely administered to a patient, and to establish a safe dose, based on the (maximum tolerated dose) MTD, for subsequent clinical testing (Phase 2 recommended dose).
Sponsor: MedImmune LLC

Current Primary Outcome: Assess safety, efficacy, characterize toxicity profile, study pharmacology and observe anti-tumor activity [ Time Frame: Disease assessment will be completed prior to the first cycle of CAT-8015 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Assess immunogenicity and potential biomarkers for response or toxicity for phase 2 dose [ Time Frame: Routine safety tests ]

Original Secondary Outcome: Same as current

Information By: MedImmune LLC

Dates:
Date Received: December 21, 2007
Date Started: May 2007
Date Completion:
Last Updated: August 6, 2015
Last Verified: August 2015