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Phase II Study of Bendamustine and Ofatumumab in Elderly Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma Who Are Poor Candidates for R-CHOP Chemotherapy

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

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Trial Information

Phase II Study of Bendamustine and Ofatumumab in Elderly Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma Who Are Poor Candidates for R-CHOP Chemotherapy

While R-CHOP has improved survival and is considered standard of care for patients with
DLBCL, the toxicities associated with R-CHOP are substantial in the elderly population.
This is one of several reasons the outcome of older patients is worse than the corresponding
younger patients. Bendamustine is an alkylating agent which causes intra- and inter-strand
cross-links between DNA bases. Ofatumumab is a fully human anti-CD 20 antibody well
tolerated by elderly patients. Ofatumumab targets a novel epitope of the CD20 molecule on B
cells and remains on the cell surface twice as long as rituximab. The combination of both
agents allows for a potentially efficacious, less toxic regimen.

Inclusion Criteria:

1. Histologically confirmed CD20-positive DLBCL.

2. Newly diagnosed, stage III-IV DLBCL considered poor candidates for R-CHOP.

3. Age >=70 years

4. At least one of the following criteria:


- Cardiac compromise precluding anthracycline therapy

- Previous anthracycline therapy for other malignancy precluding further
anthracycline therapy.

- Severe coexisting medical problems

- General frailty

5. ECOG 0-2

6. Measurable disease with at least one bidimensional lymph node or tumor mass >1.5 cm
in the longest diameter that can be followed for response as a target lesion as
measured by CT

7. Patients must be HBV sAg and HBV cAb negative within 6 weeks of screening.

8. Patient must understand and voluntarily sign the IRB-approved informed consent.

9. Life expectancy >= 3 months

10. Laboratory parameters:

- Absolute neutrophil count >=1,000 cells/mm3

- Platelet count >=75,000 cells/mm3

- Hemoglobin >=8 g/dL

- Creatinine <=2.0 mg/dL or Creatinine Clearance >= 40 mL/min (calculated or 24
hour urine sample)

- AST/SGOT <=2.0 x ULN (<=5.0 x ULN if secondary to lymphoma)

- ALT/SGPT <=2.0 x ULN (<=5.0 x ULN if secondary to lymphoma)

- Bilirubin level of <2.0 mg/dL unless secondary to Gilbert's disease (or pattern
consistent with Gilbert's)

Exclusion Criteria:

1. Patients with active/symptomatic central nervous system (CNS) involvement based on
clinical evaluation by lumbar puncture, PET, CT or MRI.

2. Known sensitivity to bendamustine or any component of bendamustine.

3. Known anaphylaxis or sensitivity to ofatumumab.

4. Major surgery within 28 days of Cycle 1, Day 1. Patients undergoing minor surgery
within 7 days of Cycle 1, Day 1. (no wait needed for port placement)

5. Prior chemotherapy, immunotherapy, or irradiation for lymphoma.

6. Prior use of investigational anti-cancer agents for lymphoma.

7. HIV-related lymphoma.

8. Known active HIV or HCV infection, or known seropositivity for HIV, or current or
chronic HBV or HCV infection. HBV test required at screening or a negative result
within 6 weeks of screening.

9. Concurrent active or history of other malignancies, except non-melanoma skin cancer
or carcinoma in situ of cervix or breast. Patients with previous malignancies are
eligible provided they have been treated with curative intent and disease free for >=
1 year.

10. Serious (grade 3-4), active, intercurrent infection requiring therapy, or deep seated
or systemic mycotic infections.

11. Myocardial infarction within 6 months prior to registration or New York Hospital
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or significant conduction system abnormalities, in the judgment of the

12. Concurrent uncontrolled serious medical or psychiatric conditions likely to interfere
with participation in this clinical study, in the judgment of the Investigator

13. Patients who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable
chronic liver disease per investigator assessment).

14. Treatment with any known non-marketed drug substance or experimental therapy within 5
terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently
participating in any other interventional clinical study.

15. Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
psychiatric disease which in the opinion of the investigator may represent a risk for
the patient.

16. Male patients unable or unwilling to use adequate contraception methods from study
start to one year after the last dose of protocol therapy.

Type of Study:


Study Design:

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

Outcome Measure:

Evaluate Complete Response Rate in Stage III-IV DLBCL

Outcome Description:

To evaluate the complete response rate (CRR) in patients with newly diagnosed Stage III-IV DLBCL considered poor candidates for R-CHOP therapy treated with the combination of ofatumumab and bendamustine.

Outcome Time Frame:

18 Months

Safety Issue:


Principal Investigator

Ian Flinn, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

June 2014

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Ofatumumab
  • Bendamustine
  • Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma Who are Poor Candidates for R-CHOP Chemotherapy
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



Tennessee Oncology, PLLCClarksville, Tennessee  37043
RHHP/ Hope Cancer CenterTerre Haute, Indiana  47802
Florida Cancer Specialists NorthFt. Myers, Florida  33916
Woodlands Medical SpecialistsPensacola, Florida  32503