Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab

Stopped early · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

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.

Key facts

Study ID

NCT01125787

Run by

Nevada Cancer Institute

People needed

1

Starts

2010-05-01

Expected to finish

2011-04-01

Last updated by the study team

2011-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be >/= 18 years old and able to provide consent
• Must have diagnosis of CLL as defined by NCI criteria
• Must be previously untreated for CLL
• Must require chemotherapy
• serum creatinine <1.8 mg/dl
• Bilirubin must be </= 2 mg/d, unless secondary to tumor
• Must have adequate liver function (as defined as <2x ULN, unless related to CLL)
• Performance status 0-2
• Women of child bearing age must be willing to use accepted/effective method of birth control.

You may not qualify if…

• Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.
• Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia
• Not have history of corticosteroid treatment for CLL
• Not have CNS disease
• Not have clinically significant infections
• Patients with a second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible.
• Not have positive serology for Hepatitis B or Hepatitis C
• Not have be known to be HIV positive
• Not have New York Classification III or IV hear disease

Where it is running

• University of Florida — Gainesville, Florida, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.