NCT00193466

Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase II Trial of Rituximab/Fludarabine Followed by CAMPATH-1H in the First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are elderly, or who are considered unlikely to tolerate this combination therapy well, will receive single agent rituximab followed by Campath-1H.

Detailed description

Upon determination of eligibility, all patients will receive: Fludarabine + Rituximab + CAMPATH-1H Patients who are judged by the investigator not to be candidates for fludarabine due to advanced age, marginal performance status or coexistent medical conditions will receive rituximab alone followed by CAMPATH-1H.

Conditions

• Non-Hodgkins Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab
DRUG	Fludarabine
DRUG	CAMPTH-1H

Timeline

• Start date: 2002-01-01
• Primary completion: 2007-01-01
• Completion: 2008-04-01
• First posted: 2005-09-19
• Last updated: 2010-12-30