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A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Follicular

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Trial Information

A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment


Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in
patients with follicular lymphoma that has relapsed following rituximab-containing therapy.
Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell
Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing
regimen during or within 6 months of the last rituximab treatment.

Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in
the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may
provide additional clinical benefit and efficacy to those who no longer respond to rituximab
or rituximab-containing regimens.

The objective of this study is to determine the effect of ofatumumab and bendamustine
combination therapy in patients with indolent B-cell NHL that did not respond to rituximab
or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.


Inclusion Criteria:



- Indolent lymphoma including Grades 1-3a follicular, small lymphocytic,
lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage
II. Tumor verified CD20+ and CT imaging done at screening verifying disease

- Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of
treatment with rituximab or a rituximab-containing regimen

- Indolent lymphoma including grades 1-3a follicular, small lymphocytic,
lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage
II (i.e. as any single mass > 5 cm in any direction)

- ECOG Performance Status of 0, 1, or 2

- Life expectancy of at least 6 months

- 18 years or older

- Signed, written informed consent

Exclusion Criteria:

- Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed
to aggressive lymphoma

- Previous allogeneic stem cell transplant

- Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy
in the past 12 months

- Previous external beam radiation therapy to the pelvis. Previous external beam
radiation therapy for bony disease to the cranium, mediastinum, and axilla, or to two
or to more than 3 vertebral bodies

- High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within
3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at
the time of randomization

- Prior bendamustine treatment within 1 year of randomization not resulting in a CR or
PR for at least 6 months

- Treatment with anti-CD20 monoclonal antibody within 3 months of randomization

- Known CNS involvement of indolent lymphoma

- Other past or current malignancy. Subjects free of malignancy for at least 5 years
or have history of definitively treated non-melanoma skin cancer, or successfully
treated in situ carcinoma, are eligible

- Chronic or current active infectious disease requiring systemic antibiotics,
antifungal, or antiviral treatment

- Clinically significant cardiac disease

- History of significant cerebrovascular disease or event with significant symptoms

- Positive serology for Hepatitis B

- Current active liver or biliary disease (except Gibler's syndrome or asymptomatic
gallstones, liver metastases, or otherwise stable chronic liver disease)

- Known HIV positive

- Abnormal/inadequate blood values, liver and kidney function

- Current participation in other clinical study

- Inability to comply with the protocol activities

- Lactating or pregnant women or female patients of child-bearing potential (or male
patients with such partners) not willing to use adequate contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free-survival following ofatumumab and bendamustine combination therapy

Outcome Time Frame:

68 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Institutional Review Board

Study ID:

110918

NCT ID:

NCT01077518

Start Date:

August 2010

Completion Date:

May 2022

Related Keywords:

  • Lymphoma, Follicular
  • Refractory
  • Safety
  • Efficacy
  • Rituximab refractory
  • Oncology
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteCoeur d'Alene, Idaho  83814
GSK Investigational SiteSeattle, Washington  98133
GSK Investigational SiteMorgantown, West Virginia  26506