Campath-1H for patients with relapsed and refractory WM

Status: CLOSED
Date: 3/1/2003
Physician: Steven Treon, MD, MA, PhD

DFCI Protocol 02-079, a multicenter Phase II clinical trial of Campath-1H chaired by Drs. Treon opened for accrual in March 2003.

This study is no longer enrolling patients.

This study will be assessing the activity of Campath-1H in patients with WM. Patients whose tumor cells are positive for CD52 and who are no longer responding to at least one front line therapy are eligible for this study. Patients on this study will receive 6 weeks of Campath-1H therapy followed by 6 weeks of Campath-1H for patients who demonstrate stable disease, minor or partial responses. The endpoints of this study will include assessment of overall response rates following 6 weeks of single agent Campath-1H therapy, assessing whether improvements in the quality of response occurs following 6 additional weeks of Campath-1H therapy, as well as response duration and toxicity. Corollary studies will be performed as part of this study to assess the role of Fc gammaRIIIa polymorphisms in determining responses along with studies evaluating immunobiological changes.