Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia
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.
Chronic Lymphocytic Leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia|
- This study will use a composite primary endpoint incorporating both tolerability and efficacy. [ Time Frame: 1-N/A ] [ Designated as safety issue: Yes ]
- Overall survival, duration of response, and the expression of ZAP-70, CD38, IgVH status, and chromosomes. [ Time Frame: 1 N/A ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||January 2013|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
|Experimental: FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB||
Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Other Name: FludarabineDrug: Cyclophosphamide
The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Other Name: CyclophosphamideDrug: Rituximab
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.
Other Name: Rituximab
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280241
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Suzanne Lentzsch, MD, PhD||University of Pittsburgh|