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

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ClinicalTrials.gov Identifier: NCT01125787
Recruitment Status : Terminated (Low enrollment)
First Posted : May 18, 2010
Last Update Posted : July 20, 2011
Information provided by:
Nevada Cancer Institute

Brief Summary:

Investigational Drug:

Ofatumumab (Azerra)

Route of Administration:

Intravenous (IV)


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.

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.


Patients will be followed monthly for six months, then every three months for five years then annually thereafter.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Drug: ofatumumab + bendamustine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2010
Primary Completion Date : August 2010
Study Completion Date : April 2011

Arm Intervention/treatment
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.
Other Names:
  • Generic: Ofatumumab Brand: Arzerra
  • Generic: Bendamustine Brand: Treanda

Primary Outcome Measures :
  1. Overall Response Rate (Efficacy)
    The primary objective for this study is to evaluate the overall response rate of bendamustine and ofatumumab in patients with previously untreated CLL.

Secondary Outcome Measures :
  1. Safety Evaluation
    1) evaluating the toxicity of patients treated with bendamustine and ofatumumab

  2. Response Rate Evaluation
    evaluate complete response rate, progression- free survival, overall survival, and time to next therapy

  3. Correlative Analysis
    determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125787

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Sponsors and Collaborators
Nevada Cancer Institute
Principal Investigator: Mark Kirschbaum, MD Nevada Cancer Institute

Responsible Party: Mark Kirschbaum, MD, Nevada Cancer Institute
ClinicalTrials.gov Identifier: NCT01125787     History of Changes
Other Study ID Numbers: NVCI 09-14
C18083/6264 ( Other Identifier: Cephalon )
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Nevada Cancer Institute:
blood cancer
non-Hodgkin lymphoma
small lymphocytic lymphoma
nevada cancer institute

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Bendamustine Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs