NCT00538096

A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma

A Phase I, Multicenter, Open-Label, Single-Arm, Dose-Escalation, Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of the Bispecific T-Cell Engager MEDI-538 in Adults With B-Cell Non-Hodgkin's Lymphoma Not Eligible for Curative Therapy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

* Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy. * Determine the maximum tolerated dose of MEDI-538 administered by continuous IV infusion.

Detailed description

* Evaluate the safety and tolerability of MEDI-538 at doses of 5, 10, or 15 μg/m2/24h by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for * Determine the MTD of MEDI-538 administered by continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative therapy.

Conditions

• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	MEDI-538	1 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
DRUG	MEDI-538	1 of 3 target doses of MEDI-538 (10,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
DRUG	MEDI-538	1 of 3 target doses of MEDI-538 (15,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2007-10-02
• Last updated: 2008-09-05