Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

Phase 1/2 Completed 31 enrolled Biogen

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open label, Phase I/II, dose escalation research study of an investigational product called lumiliximab, given with FDA (Food and Drug Administration) approved products fludarabine, cyclophosphamide, and rituximab (FCR). The study duration is 17 visits over 42 months or until your disease progresses and you require additional CLL therapy. The total duration of participation in the study will be approximately 4 years, however your disease status will be followed indefinitely (forever).

Timeline

Start: 2004-03
Primary completion: 2010-01
Completion: 2010-03

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumiliximab	Monoclonal antibody	375 mg/m2	—
Subject	Lumiliximab	Monoclonal antibody	500 mg/m2	—
Background	Cyclophosphamide	Other / unclassified	—	—
Background	Fludarabine	Small molecule	—	—
Background	Rituximab	Monoclonal antibody	—	—

Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

Summary

Timeline

Publications

Drugs

Indications