Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia Fludarabine Cyclophosphamide Rituximab
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief summary:
This research study will look at the effects (good or bad) of administering cyclophosphamide, fludarabine, and rituximab. Clinical studies with combination therapy have shown higher response rates than using single drugs, and this study will evaluate the side effects and effectiveness of this combination.

Detailed description:
This study is designed to expand on the highly successful combination of rituximab, fludarabine and cyclophosphamide for patients with previously untreated CLL. Responses in the range of 90-98% with 55% complete responses are reported. However, bone marrow toxicity has been a significant problem. This trial is designed to reduce the bone marrow toxicity by decreasing the doses of fludarabine and cyclophosphamide, but doubling the dose of rituximab with a maintenance dose of rituximab for up to two years, to maintain or even enhance efficacy.

Arms:
arm 1: None

Interventions: intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Rituximab
Intervention descriptions: intervention 1: Fludarabine is usually administered by IV infusion over 30 minutes or longer. intervention 2: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour. intervention 3: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.

Protocol document: