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A Phase II Trial of Bendamustine in Combination With Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Phase 2
65 Years
Open (Enrolling)
Diffuse Large B-Cell Lymphoma, Lymphoma, Diffuse Large-Cell, Diffuse Large-Cell Lymphoma, Lymphoma

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Trial Information

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.

Inclusion Criteria:

- Patients with previously untreated , histologically confirmed, diffuse large
B-cell lymphoma (DLBCL), immunophenotyped for CD20

- Age greater than or equal to 65 years

- Stage II-IV

- Measurable disease including lesions that can be accurately measured in 2 dimensions
by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone
marrow histopathology.

- ECOG performance status of 0-3

- Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%,
ECOG performance status of 2, or in the opinion of the treating physician, patient
would not tolerate administration of CHOP-R chemotherapy for other reasons,

- Life expectancy of at least 3 months;

- Documented negative serologic testing for HIV, Hepatitis B (unless positive due to
prior vaccination), and hepatitis C within the year prior to enrollment

- Adequate bone marrow function (without transfusion support within one week of
screening) function:

- Hemoglobin > 8 g/dL

- Absolute neutrophil count (ANC) >1000 cells/mm3

- Platelet count > 75,000/mm3

- Adequate hepatic and renal function as demonstrated by:

- Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)

- Total serum bilirubin < 2.5 x ULN

- Serum creatinine < 1.5 x ULN

- If sexually active male of reproductive capability, has agreed to use a medically
accepted form of contraception from time of enrollment to completion of all follow-up
study visits

- Signed an institutional review board (IRB) approved informed consent document

Exclusion Criteria:

- Central nervous system involvement by lymphoma

- History of previous allergic reactions to compounds of similar biological or chemical
composition as rituximab or bendamustine

- Medical or other condition that would represent an inappropriate risk to the patient
or would likely compromise achievement of the primary study objective.

- Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in
situ without evidence of disease, prostatic intraepithelial neoplasia without
evidence of prostate cancer)

- Patients on strong inhibitors of CYP1A2.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response (CR) rate as defined by The International Harmonization Project for Response Criteria

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steven Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:

LCCC 1011



Start Date:

November 2010

Completion Date:

November 2016

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Lymphoma, Diffuse Large-Cell
  • Diffuse Large-Cell Lymphoma
  • Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Elderly
  • Newly Diagnosed
  • Lineberger Comprehensive Cancer Center
  • University of North Carolina
  • Bendamustine
  • Rituximab
  • Rituxan
  • Treanda
  • Phase 2
  • Geriatric
  • Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Northeast Medical CenterConcord, North Carolina  28025
Rex HealthcareRaleigh, North Carolina  27607
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Marion L. Shepard Cancer CenterWashington, North Carolina  
Moses Cone Regional Cancer CenterGreensboro, North Carolina  27403
Seby B. Jones Cancer CenterBoone, North Carolina  28607
Leo Jenkins Cancer Center, East Carolina University Medical CenterGreenville, North Carolina  27834