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

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborators:
GlaxoSmithKline
Cephalon
Information provided by:
Nevada Cancer Institute
ClinicalTrials.gov Identifier:
NCT01125787
First received: May 14, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Drug: ofatumumab + bendamustine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/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 PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

Resource links provided by NLM:


Further study details as provided by Nevada Cancer Institute:

Primary Outcome Measures:
  • Overall Response Rate (Efficacy) [ Designated as safety issue: No ]
    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:
  • Safety Evaluation [ Designated as safety issue: Yes ]
    1) evaluating the toxicity of patients treated with bendamustine and ofatumumab

  • Response Rate Evaluation [ Designated as safety issue: No ]
    evaluate complete response rate, progression- free survival, overall survival, and time to next therapy

  • Correlative Analysis [ Designated as safety issue: No ]
    determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.


Enrollment: 1
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125787

Locations
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
GlaxoSmithKline
Cephalon
Investigators
Principal Investigator: Mark Kirschbaum, MD Nevada Cancer Institute
  More Information

No publications provided

Responsible Party: Mark Kirschbaum, MD, Nevada Cancer Institute
ClinicalTrials.gov Identifier: NCT01125787     History of Changes
Other Study ID Numbers: NVCI 09-14, C18083/6264
Study First Received: May 14, 2010
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Nevada Cancer Institute:
CLL
bendamustine
ofatumumab
blood cancer
leukemia
lymphocyte
hematology
non-Hodgkin lymphoma
small lymphocytic lymphoma
nevada cancer institute
cephalon
Glaxosmithkline

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

ClinicalTrials.gov processed this record on September 16, 2014