Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Boone, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT01234467
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
  • Rituximab — DRUG
    Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Study Details

The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers are interested in learning about how this cancer treatment affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. GAs are also designed to help the health care team understand how well subjects can carry out their day to day activities and to briefly describe what other medical conditions subjects may have. This assessment will help the health care team understand a subject's "functional age" (the age a subject functions at) as compared to a subject's actual age. The researchers also want to learn how chemotherapy affects the aging process in our bodies. This is done by measuring the amount of p16 in blood. Researchers want to understand if chemotherapy changes the levels of p16 in blood.

Key Dates

Start date
Mar 31, 2011
Status verified
Apr 2017
Primary completion
Dec 31, 2013
Completion
Aug 31, 2016

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustine, Rituximab
    This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.

Primary Outcome Measure

Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria [ Time Frame: 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Seby B. Jones Cancer CenterBooneNorth Carolina28607-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Northeast Medical CenterConcordNorth Carolina28025-
Moses Cone Regional Cancer CenterGreensboroNorth Carolina27403-
Leo Jenkins Cancer Center, East Carolina University Medical CenterGreenvilleNorth Carolina27834-
Rex HealthcareRaleighNorth Carolina27607-
Marion L. Shepard Cancer CenterWashingtonNorth Carolina27889-

Find similar trials in Boone, NC

By research site
Seby B. Jones Cancer Center· Boone, NCUniversity of North Carolina at Chapel Hill· Chapel Hill, NCNortheast Medical Center· Concord, NCMoses Cone Regional Cancer Center· Greensboro, NCLeo Jenkins Cancer Center, East Carolina University Medical Center· Greenville, NCRex Healthcare· Raleigh, NC

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