Chronic Lymphocytic Leukemia (CLL) Clinical Trial
Official title:
PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
Investigational Drug:
Ofatumumab (Azerra)
Route of Administration:
Intravenous (IV)
Hypothesis:
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.
Participation:
Approximately 38 previously untreated CLL subjects will participate in this study over two
years.
Treatment Plan:
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.
Follow-up:
Patients will be followed monthly for six months, then every three months for five years
then annually thereafter.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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