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Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758693
Recruitment Status : Withdrawn (Funding was withdrawn due to insufficient accrual)
First Posted : September 25, 2008
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
University of Kentucky

Brief Summary:
Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Bendamustine Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia: A Phase II Study
Study Start Date : October 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: 1
Bendamustine + Rituximab
Drug: Bendamustine
Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles
Other Name: Treanda

Drug: Rituximab
Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles
Other Name: Rituxan

Primary Outcome Measures :
  1. Determine the response rate [ Time Frame: Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL ]

Secondary Outcome Measures :
  1. Describe the toxicity rates and severities [ Time Frame: Up to 2 years after enrollment ]
  2. Describe the quality of life participants experience while receiving this combination therapy [ Time Frame: Up to 2 years after enrollment ]
  3. Determine the health utility scores of participants while receiving this combination therapy [ Time Frame: Up to 2 years after enrollment ]
  4. Conduct exploratory analyses of associations between clinical responses and protein expression and phosphorylation using novel flow cytometry methods [ Time Frame: Pre and Post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed chronic lymphocytic leukemia.
  • A minimum of any one of the following disease-related symptoms must be present:

    • Weight loss ≥10% within the previous 6 months.
    • Extreme fatigue (ie, ECOG PS 2; cannot work or unable to perform usual activities).
    • Fevers of greater than 100.5"F for ≥ 2 weeks without evidence of infection.
    • Night sweats without evidence of infection. or
    • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia or
    • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy or
    • Massive (ie, >6 cm below the left costal margin) or progressive splenomegaly or
    • Massive nodes or clusters (ie, > 10 cm in longest diameter) or progressive lymphadenopathy or
    • Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months but
    • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy
  • No prior therapy for CLL is allowed. Participants may have taken corticosteroids previously but must be ≥ 28 days from last dose prior to enrolment.
  • Age >65 years.
  • Life expectancy of greater than 1 year.
  • ECOG performance status better than or equal 2.
  • Patients must have normal organ and marrow function as defined below:

    • total bilirubin within normal institutional limits unless resulting from documented hemolysis
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had previous chemotherapy or radiotherapy for the treatment of CLL.
  • Patients may not be receiving any other investigational agents.
  • Patients with known brain involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bendamustine or rituximab.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Patients with a known history of viral hepatitis, with the exception of Hepatitis A that has recovered.
  • Patients who require concomitant treatment with CYP1A2 inhibitors including: Cimetidine, Ciprofloxacin, Fluvoxamine, Ticlopidine.

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 identifier (NCT number): NCT00758693

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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
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Principal Investigator: John Hayslip, MD, MSCR University of Kentucky

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Responsible Party: University of Kentucky Identifier: NCT00758693     History of Changes
Other Study ID Numbers: 08-LEUK-07-MCC/CI
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: September 2011
Keywords provided by University of Kentucky:
Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action