Clinical trial NCT01125787: Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab
Official title: PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: CLL
bendamustine
ofatumumab
blood cancer
leukemia
lymphocyte
hematology
non-Hodgkin lymphoma
small lymphocytic lymphoma
nevada cancer institute
cephalon
Glaxosmithkline
Lead sponsor: Nevada Cancer Institute
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Cephalon
First posted: 2010-05-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Response Rate (Efficacy)
Secondary outcomes:
measure: Safety Evaluation
measure: Response Rate Evaluation
measure: Correlative Analysis
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
Study officials:
affiliation: Nevada Cancer Institute
name: Mark Kirschbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: