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Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy | Clinical Trials | Clareo Health

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Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Randomized Open Label of Ofatumumab and Bendamustine Combination 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

NCT01077518•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the safety and efficacy 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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (140)

Novartis Investigative Site

Tucson, Arizona, United States

Novartis Investigative Site

Beverly Hills, California, United States

Novartis Investigative Site

Palm Springs, California, United States

Novartis Investigative Site

Washington D.C., District of Columbia, United States

Novartis Investigative Site

Atlanta, Georgia, United States

Novartis Investigative Site

Coeur d'Alene, Idaho, United States

Novartis Investigative Site

Silver Spring, Maryland, United States

Novartis Investigative Site

Detroit, Michigan, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Mineola, New York, United States

Key Dates

Start Date

August 26, 2010

Primary Completion Date

January 3, 2018

Completion Date

December 26, 2018

Last Updated

March 27, 2020

Enrollment

346

ACTUAL participants

Conditions

Lymphoma, Follicular

Interventions

Ofatumumab

DRUG

Bendamustine infusion

DRUG

Ofatumumab and Bendamustine infusions (Arm A)

DRUG

Bendamustine infusion (Arm B)

DRUG

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B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Inclusion Criteria

Exclusion Criteria

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