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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
University of Kentucky
Study ID
NCT00758693
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bendamustine — DRUG
    Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles
  • Rituximab — DRUG
    Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles

Study Details

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.

Key Dates

Start date
Oct 31, 2008
Status verified
Sep 2011
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Bendamustine + Rituximab

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536-

Find similar trials in Lexington, KY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Kentucky· Lexington, KY

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