WARNING: HEPATITIS B VIRUS (HBV) REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
Hepatitis B Virus Reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA®, in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnings and Precautions].
Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautions].
ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa.
Previously Untreated Chronic Lymphocytic Leukemia
ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate [see
ARZERRA is indicated for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies].
Media Articles Related to Arzerra (Ofatumumab)
FDA approve Arzerra (ofatumumab) as extended treatment for recurrent or progressive chronic lymphocytic leukemia
Source: Blood / Hematology News From Medical News Today [2016.01.20]
Genmab A/S has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) for extended...
Bone loss associated with leukemia therapy occurs sooner than previously thought
Source: Bones / Orthopedics News From Medical News Today [2016.02.05]
Investigators at Children's Hospital Los Angeles have found that significant bone loss - a side effect of chemotherapy for acute lymphoblastic leukemia (ALL) - occurs during the first month of...
New assay detects persistent disease in leukemia patients thought to be in remission
Source: Blood / Hematology News From Medical News Today [2016.02.04]
The outcomes of chronic myeloid leukemia (CML) have dramatically improved as the result of tyrosine kinase inhibitor (TKI) treatment.
Source: MedicineNet Anemia Specialty [2016.02.03]
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 2/3/2016 12:00:00 AM
Standard BMI inadequate for tracking obesity during leukemia therapy
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.01.29]
An interdisciplinary research team at The Saban Research Institute of Children's Hospital Los Angeles has found that body mass index (BMI) is an inadequate method for estimating changes in body fat...
Published Studies Related to Arzerra (Ofatumumab)
Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a
phase 2 study. 
sclerosis (RRMS)... CONCLUSIONS: Ofatumumab (up to 700 mg) given 2 weeks apart was not associated
Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive,
rheumatoid arthritis patients with an inadequate response to methotrexate: a
randomised, double-blind, placebo-controlled clinical trial. 
arthritis (RA) patients despite methotrexate treatment... CONCLUSIONS: Ofatumumab significantly improved all clinical outcomes in
Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomized, double-blind, placebo-controlled, phase I/II study. [2010.08]
OBJECTIVE: To investigate the safety and efficacy of ofatumumab, a novel human anti-CD20 monoclonal antibody (mAb), in patients with active rheumatoid arthritis (RA) whose disease did not respond to > or = 1 disease-modifying antirheumatic drug... CONCLUSION: Our findings indicate that ofatumumab, administered as 2 i.v. infusions of doses up to 1,000 mg, is clinically effective in patients with active RA.
Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated
patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised,
multicentre, open-label phase 3 trial. 
have few treatment options... INTERPRETATION: Addition of ofatumumab to chlorambucil led to clinically
Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II
study of safety, tolerability, pharmacokinetics, and pharmacodynamics. 
objectives included characterizing pharmacokinetics and pharmacodynamics... CONCLUSION: Treatment of RA patients with SC ofatumumab doses of 30 mg or higher
Clinical Trials Related to Arzerra (Ofatumumab)
Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia [Recruiting]
This is a Phase II, single-arm study of ofatumumab investigating the safety of an
accelerated infusion schedule of ofatumumab in patients who have received at least one prior
therapy for CLL. The primary endpoint is to evaluate the number of subjects able to
complete infusion number 3 (2000 mg) within 15 minutes of the planned time.
Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide for Refractory or Relapsed Aggressive B-Cell Lymphomas [Recruiting]
The Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to
define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of
bendamustine, ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin's lymphoma
whose disease has progressed or has recurred after prior chemotherapy.
The Phase II part of the study will be a single-arm, open-label study in which all patients
will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose
defined in phase I.
This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin's
Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The
hypothesis is that the proposed combination of chemotherapy is well-tolerated and is
efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.
Hyper CVAD Plus Ofatumumab in CD - 20 Positive Acute Lymphoblastic Leukemia (ALL) [Recruiting]
The goal of this clinical research study is to learn if ofatumumab combined with standard
chemotherapy can help to control ALL. The safety of these drug combinations will also be
Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma [Recruiting]
This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab
(PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell
Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal
dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how
safe these three drugs work together.
Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL) [Completed]
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will
be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three
consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR)
to therapy and the secondary endpoints will assess the safety and tolerability of the
regimen, the impact of the treatment on progression free, treatment free, overall survival,
and pharmacokinetics of ofatumumab. Patients will receive allopurinol for tumor-lysis
prophylaxis and antimicrobial prophylaxis.
Reports of Suspected Arzerra (Ofatumumab) Side Effects
Infusion Related Reaction (11),
Febrile Neutropenia (9),
Neuropathy Peripheral (5),
Lymphadenopathy (3), more >>
Page last updated: 2016-02-05