PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab
Ofatumumab (Azerra) + bendamustine (Trenda)
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. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.
Approximately 37 relapsed/refractory 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: 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 RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB|
- Overall Response Rate/ Efficacy [ Designated as safety issue: No ]The primary objective for this trial is to evaluate the overall response rate (CR+PR) of bendamustine and ofatumumab in patients with relapsed/refractory CLL.
- Safety Evaluation [ Designated as safety issue: Yes ]The first secondary objective is to evaluate the toxicity of patients with relapsed/refractory CLL treated with bendamustine and ofatumumab.
- Response Rate [ Designated as safety issue: No ]Other secondary objectives include: evaluating the complete response rate, progression-free survivial, overal survival and time to next therapy
- Correlative Analysis [ Designated as safety issue: No ]This study also aims to determine whether expression of of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival
|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, Arizona|
|PHoenix/Scottsdale, Arizona, United States, 85259|
|Principal Investigator:||Mark Kirschbaum, MD||Nevada Cancer Institute|
|Principal Investigator:||Jose Leis, MD||Mayo Clinic|