A Phase II Trial of Bendamustine in Combination With Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
This multicenter Phase II clinical study will investigate the complete response (CR) rate
after therapy with bendamustine combined with rituximab in older (≥65 years old) patients
with previously untreated stage II-IV DLBCL deemed poor candidates for cyclophosphamide,
doxorubicin hydrochloride, vincristine (Oncovin®), prednisone, rituximab (CHOP-R); n=37. The
hypothesis being tested is that this regimen will be safe and effective as frontline therapy
in older DLBCL patients deemed poor candidates for CHOP-R. After 3 cycles of therapy,
patients with less than a partial response (PR) will come off study, and be managed at the
discretion of their treating physician. Patients who achieve a PR after 3 cycles will
continue for a total of 8 cycles of therapy, while patients who achieve a CR will continue
for a total of 6 cycles of therapy. Secondary objectives include overall response rates
(ORR), disease-free, progression-free and overall survival, and an evaluation of the
toxicity and tolerability of the regimen.
This trial also includes an exploratory analysis designed to evaluate a potential
correlation between expression of the senescence marker p16INK4a and the toxicity associated
with this regimen.
In addition, patients will be asked to participate in a Geriatric Assessment (GA) tool
during the trial.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response (CR) rate as defined by The International Harmonization Project for Response Criteria
2 years
No
Steven Park, MD
Principal Investigator
University of North Carolina, Chapel Hill
United States: Institutional Review Board
LCCC 1011
NCT01234467
November 2010
November 2016
Name | Location |
---|---|
Northeast Medical Center | Concord, North Carolina 28025 |
Rex Healthcare | Raleigh, North Carolina 27607 |
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
Marion L. Shepard Cancer Center | Washington, North Carolina |
Moses Cone Regional Cancer Center | Greensboro, North Carolina 27403 |
Seby B. Jones Cancer Center | Boone, North Carolina 28607 |
Leo Jenkins Cancer Center, East Carolina University Medical Center | Greenville, North Carolina 27834 |