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

NCT ID: NCT00758693

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-07-31

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Bendamustine + Rituximab

Group Type: EXPERIMENTAL

Bendamustine

Intervention Type: DRUG

Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles

Rituximab

Intervention Type: DRUG

Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles

Interventions

Bendamustine

Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles

Intervention Type: DRUG

Rituximab

Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles

Intervention Type: DRUG

Other Intervention Names

Treanda; Rituxan

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Hayslip, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Related Links

http://markey.uky.edu/studysearch/default.aspx?site=Blood%20and%20Marrow%20Transplant

Markey Cancer Center Blood and Marrow Transplant Study Search

Other Identifiers

08-LEUK-07-MCC/CI

Identifier Type: -

Identifier Source: org_study_id