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

NCT00758693 | Withdrawn Phase 2

• 1 other identifier: 08-LEUK-07-MCC/CI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Lymphocytic Leukemia; Bendamustine; Treanda; Rituximab; Rituxan

Outcome Measures

Primary Outcomes (1)

• Determine the response rate

  Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL

Secondary Outcomes (4)

• Describe the toxicity rates and severities

  Up to 2 years after enrollment

• Describe the quality of life participants experience while receiving this combination therapy

  Up to 2 years after enrollment

• Determine the health utility scores of participants while receiving this combination therapy

  Up to 2 years after enrollment

• Conduct exploratory analyses of associations between clinical responses and protein expression and phosphorylation using novel flow cytometry methods

  Pre and Post treatment

Study Arms (1)

1

EXPERIMENTAL

Bendamustine + Rituximab

Drug: Bendamustine; Drug: Rituximab

Interventions

Bendamustine DRUG

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

Also known as: Treanda

1

Rituximab DRUG

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

Also known as: Rituxan

1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kentucky: lead
• Cephalon: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Links

• Markey Cancer Center Blood and Marrow Transplant Study Search

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John Hayslip, MD, MSCR

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 25, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 11, 2012

Record last verified: 2011-09

Locations

US (1)