BR in Patients With CLL With Comorbidities and/or Renal Dysfunction

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT01832922
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are FDA approved for this indication. However, full dose bendamustine is associated with significant hematologic toxicity and a high rate of infectious complications in "unfit" patients and patients with significantly impaired renal function. This study will attempt to optimize and define adequate and safe treatment protocols for these patients with comorbidities and/or renal dysfunction. The study will accrue two independent patient cohorts which will follow a standard Phase I design. Patients with CLL who have significant comorbidities with or without minor renal dysfunction (CrCL\>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with significant renal dysfunction (CrCL\<40 mL/min) will be accrued onto Cohort 2. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled. There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to 9 patients with renal dysfunction will also provide samples for bendamustine PK analysis. Accrual of both patient cohorts will occur simultaneously and will take place at two centers: Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI). Coordination of accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V. Danilov.

Key Dates

Start date
Apr 30, 2013
Status verified
Mar 2018
Primary completion
Apr 27, 2015
Completion
Nov 28, 2016

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Significant Comorbidiities
    Significant comorbidities as defined by Cumulative Illness Rating Score (CIRS) of ≥7.
  • Active Comparator: Significant renal dysfunction
    Significant renal dysfunction defined as CrCL 15-40 mL/min, but not receiving dialysis.

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: within the first 30 days of treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer CenterLebanonNew Hampshire03750-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dana Farber Cancer Institute· Boston, MADartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center· Lebanon, NH

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