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

January 10, 2012 updated by: University of Kentucky

Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia: A Phase II Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Treanda
Drug: Rituximab
Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles
Other Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the response rate
Time Frame: Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL
Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kentucky

Collaborators

Cephalon

Investigators

  • Principal Investigator: John Hayslip, MD, MSCR, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-LEUK-07-MCC/CI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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