A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of MEDI-538 in Adults With B-Cell Chronic Lymphocytic Leukemia (CLL)

PHASE1/PHASE2WithdrawnINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

June 30, 2011

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

MEDI-538

Dose one of MEDI 538 as a continuous IV infusion - dose level is 5 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose two of MEDI 538 as a continuous IV infusion - dose level is 10 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose three of MEDI 538 as a continuous IV infusion-dose level is 15mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose four of MEDI 538 as a continuous IV infusion - dose level is 30 mg/m2/24h(Phase 1)

DRUG

MEDI-538

Dose five of MEDI 538 as a continuous IV infusion - dose level is 45 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Dose six of MEDI 538 as a continuous IV infusion - dose level is 60 mg/m2/24h (Phase 1)

DRUG

MEDI-538

Phase 2 part of the study, 20 to 60 patients will be treated with MEDI 538 as a continuous IV infusion through a central line catheter. The dose of MEDI-538 will be determined in the Phase 1 part of the study.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY

NCT00676871 - A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of MEDI-538 in Adults With B-Cell Chronic Lymphocytic Leukemia (CLL) | Biotech Hunter | Biotech Hunter