Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia CD-52 and CD-20 Positive Refractory Relapsed
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 48
Healthy volunteers: no

Brief summary:
The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.

Detailed description:
Objectives:

1. To determine the efficacy and response rates of Campath-1H when given as a continuous intravenous infusion followed by subcutaneous injection plus rituximab in the treatment of chronic lymphoid disorders that are refractory to conventional therapy, have relapsed, or have no established frontline therapy.
2. To assess the safety of the combination of Campath-1H when given as a continuous intravenous infusion followed by subcutaneous injection plus rituximab in chronic lymphoid disorders that express both CD52 and CD20 cell surface antigens.
3. To measure levels of soluble (s) CD20 and sCD52 as well as levels of Campath-1H, rituximab and antibody complexes of rituximab/CD20 and Campath-1H/CD52 in patients with chronic lymphoid disorders treated with Campath-1H plus rituximab.

Arms:
arm 1: Campath 15 mg/day continuous intravenous (IV) infusion x 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.

Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.

Interventions: intervention 1: Campath-1H intervention 2: Rituximab
Intervention descriptions: intervention 1: 15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks. intervention 2: 375 mg/m\^2 IV infusion on day 1, then 500 mg/m\^2 on days 8, 15, and 22.

Protocol document: