Neoplasms

Blood and Lymph Conditions

Immune System Diseases

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Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Leukemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Leukemia, B-Cell

Leukemia, Lymphoid

Hematologic Diseases

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Lymphocytic Leukemia

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Indolent B Cell Lymphoma

Chronic Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Ofatumumab

ofatumumab

Jeremy S. Abramson, MD

Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of cancerous B cells, and then triggering the death of those cells. It is approved by the FDA for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence of success in people who's B-cell lymphomas have relapsed after initial treatments. In this research study we are looking to see if ofatumumab is effective and safe in treating previously untreated B-cell NHL.

* Participants will receive ofatumumab once a week for 8 weeks by intravenous infusion (Days 1, 8, 15, 22, 29, 36, 43, and 50).
* Participants will be seen weekly during the 8 week treatment period and will have the following tests and procedures performed: Blood tests, performance status and physical examination.

Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Phase II Trial Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR).

Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\<=1.5 cm in greatest diameter)

Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR).

Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (\<=1.5cm in greatest diameter) PR = \>=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT

Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse

Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

GlaxoSmithKline

Massachusetts General Hospital

Director, Lymphoma Program

single-arm, open-label, interventional

ofatumumab: Weekly infusion for 8 weeks

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Lymphoma type

Jeremy Abramson, MD

Efficacy: Complete Response Rate (CRR)

Overall Response Rate (ORR)

Progression-free Survival (PFS)

Infusion reactions (grade 1-2)

Infusion reactions (grade 3)

Infections (grade 3-4)

Neutropenia (grade 3-4)

Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia

Overall Study

Spots Global Cancer Trial Database for Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Useful links and downloads for this trial