Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab
Route of Administration:
This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone.
Approximately 38 previously untreated CLL subjects will participate in this study over two years.
A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.
Patients will be followed monthly for six months, then every three months for five years then annually thereafter.
Chronic Lymphocytic Leukemia (CLL)
Drug: ofatumumab + bendamustine
|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 WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB|
- Overall Response Rate (Efficacy) [ Designated as safety issue: No ]The primary objective for this study is to evaluate the overall response rate of bendamustine and ofatumumab in patients with previously untreated CLL.
- Safety Evaluation [ Designated as safety issue: Yes ]1) evaluating the toxicity of patients treated with bendamustine and ofatumumab
- Response Rate Evaluation [ Designated as safety issue: No ]evaluate complete response rate, progression- free survival, overall survival, and time to next therapy
- Correlative Analysis [ Designated as safety issue: No ]determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.
|Study Start Date:||May 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Experimental: ofatumumab + bendamustine||
Drug: ofatumumab + bendamustine
Loading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only.
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|United States, Nevada|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
|Principal Investigator:||Mark Kirschbaum, MD||Nevada Cancer Institute|