Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00280241|
Recruitment Status : Completed
First Posted : January 20, 2006
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia|
|Study Start Date :||June 2004|
|Primary Completion Date :||February 2008|
|Study Completion Date :||January 2013|
|Experimental: FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB||
Fludarabine is usually administered by IV infusion over 30 minutes or longer.Drug: Cyclophosphamide
The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.Drug: 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.
- Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL [ Time Frame: Duration of treatment on study ]The number of patients who experience any grade 3-5 toxicity.
- Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL [ Time Frame: Three months after the sixth cycle (9 months) ]The number of patients who experience a complete clinical response.
- Overall Survival Rate [ Time Frame: Five years after starting rituximab, cyclophosphamide and fludarabine ]The percentage of participants who are still alive.
- Duration of Response [ Time Frame: From complete response to the time of progressive disease, death or last clinical examination ]The length of time for which the complete response is maintained.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280241
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Micahel Boyiadzis, MD||University of Pittsburgh|