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An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Phase 2
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma (NHL)

Thank you

Trial Information

An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)


Inclusion Criteria:

- The patient has histopathologic confirmation of one of the protocol-specific CD20+
B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed
within 6 months of study entry and with biopsy material available for review.

- The patient meets 1 of the following need-for-treatment criteria:

1. Presence of at least 1 of the following B-symptoms:

- fever (>38ºC) of unclear etiology

- night sweats

- weight loss of greater than 10% within the prior 6 months

2. large tumor mass (bulky disease) characterized by lymphomas with a diameter of
more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more
than 7 cm in 1 region

3. presence of lymphoma-related complications

4. hyperviscosity syndrome due to monoclonal gammopathy

- The patient's tumor is verified to be CD20+ positive from current or previous
excisional or incisional tissue diagnostic procedures performed within 6 months of
study entry.

- The screening phase CT scan (based on local evaluation) shows:

- 2 or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or

- 1 clearly demarcated lesion with a largest diameter ≥2.0 cm

- The patient was not previously treated for indolent lymphoma (with the exception of a
single course of local radiation therapy not exceeding 2 adjacent lymph node

- The patient has adequate hematologic and hepatic function.

- The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or

- The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30
mL/min or more, based on the Cockcroft-Gault method, or from a 24-hour urine

- The patient is willing to comply with contraception requirements.

Key Exclusion Criteria:

The patient:

- Has small lymphocytic lymphoma or mantle cell lymphoma.

- Has documented history of central nervous system (CNS) lymphomatous involvement.

- Has or has had an active malignancy, other than NHL, within the past 3 years except
for localized prostate cancer without evidence of bone metastases, bladder, cervical,
or breast carcinoma in-situ, or non-melanoma skin cancer .

- Has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled
arrythmias or unstable angina, electrocardiographic evidence of active ischemia or
active conduction system abnormalities, or myocardial infarction within the last 6

- Has known human immunodeficiency virus (HIV) infection.

- Has acute or chronic hepatitis B or hepatitis C infection.

- Is a pregnant or lactating woman. (Any women becoming pregnant during the study will
be withdrawn from the study.)

- Has any serious uncontrolled, medical or psychological disorder that would impair the
ability of the subject to receive study drugs.

- Has received another investigational agent within 30 days of study entry.

- Has known hypersensitivity to mannitol.

- Has Ann Arbor stage I disease.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators

Outcome Description:

The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.

Outcome Time Frame:

up to Week 32

Safety Issue:


Principal Investigator

Sponsor's Medical Expert

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

October 2011

Related Keywords:

  • Non-Hodgkin's Lymphoma (NHL)
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



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