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Arzerra (Ofatumumab) - Summary

 
 



ARZERRA SUMMARY

ARZERRA (ofatumumab) is an IgG1k human monoclonal antibody with a molecular weight of approximately 149 kDa.

ARZERRA™ (ofatumumab) is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.

The effectiveness of ARZERRA is based on the demonstration of durable objective responses [see Clinical Studies]. No data demonstrate an improvement in disease related symptoms or increased survival with ARZERRA.


See all Arzerra indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Arzerra (Ofatumumab)

Discovery of possible genetic link in pediatric leukemia treatment-related cognitive issues
Source: Genetics News From Medical News Today [2014.12.13]
Common variations in four genes related to brain inflammation or cells' response to damage from oxidation may contribute to the problems with memory, learning and other cognitive functions seen in...

Potential to predict which patients are at risk of developing therapy-related acute myeloid leukemia
Source: Cancer / Oncology News From Medical News Today [2014.12.11]
For a small percentage of cancer patients, treatment aimed at curing the disease leads to a form of leukemia with a poor prognosis.

Combination chemotherapy for aggressive acute myeloid leukemia reduces adverse effects; older patient population benefits
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.11]
Patients who relapse in their battle with acute myeloid leukemia (AML) may benefit from a phase three study of therapies that combine an existing agent, cytarabine, with a newer compound, vosaroxin.

New kind of targeted drug shows promise for leukemia patients
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
A new type of cancer therapy that targets an oncometabolite produced dramatic results in patients with advanced leukemia in an early-phase clinical trial. The study, led by Eytan M.

Latest results of investigational cellular therapy in pediatric acute lymphoblastic leukemia, and first results of lymphoma trial
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
The latest results of clinical trials of more than 125 patients testing an investigational personalized cellular therapy known as CTL019 was presented by a University of Pennsylvania research team at...

more news >>

Published Studies Related to Arzerra (Ofatumumab)

Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. [2014]
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. [2011]
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.

Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. [2013]
objectives included characterizing pharmacokinetics and pharmacodynamics... CONCLUSION: Treatment of RA patients with SC ofatumumab doses of 30 mg or higher

Rituximab, ofatumumab and other monoclonal anti-CD20 antibodies for chronic lymphocytic leukaemia. [2012]
CONCLUSIONS: This meta-analysis showed that patients receiving

more studies >>

Clinical Trials Related to Arzerra (Ofatumumab)

PH2 Trial in Patietns With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab [Not yet recruiting]
Investigational Drugs:

Ofatumumab (Azerra) + bendamustine (Trenda)

Route of Administration:

Intravenous (IV)

Hypothesis:

This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.

Participation:

Approximately 37 relapsed/refractory CLL subjects will participate in this study over two years.

Treatment Plan:

A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.

Follow-up:

Patients will be followed monthly for six months, then every three months for five years then annually thereafter.

Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combinaton of Bendamustine and Ofatumumab [Recruiting]
Investigational Drug:

Ofatumumab (Azerra)

Route of Administration:

Intravenous (IV)

Hypothesis:

This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone.

Participation:

Approximately 39 previously untreated CLL subjects will participate in this study over two years.

Treatment Plan:

A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.

Follow-up:

Patients will be followed monthly for six months, then every three months for five years then annually thereafter.

Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects [Recruiting]
Ofatumumab is a fully-human monoclonal antibody that exhibits high binding affinity to an antigen on the surface of B lymphocytes. Antigen engagement by ofatumumab results in maximal B-cell killing through complement-dependent cytotoxicity and antigen-dependent cellular cytotoxicity in both antigen high- and low-expressing cells. Recent research has shown that ofatumumab-dependent B-cell depletion provides clinical benefit to subjects with CD20-positive cancers such as chronic lymphocytic leukemia (CLL). The purpose of the current study is to assess the impact of ofatumumab on electrocardiographic parameters with particular focus on cardiac repolarization (QTc interval duration) in subjects with refractory CLL. Subjects enrolled in this open-label, single-arm trial will receive ofatumumab at the highest clinical dose (2000 mg) studied or planned for study. Ofatumumab will be administered as eight weekly intravenous (IV) infusions followed by four monthly infusions, beginning in Week 13, across a 25-week treatment period. Cardiovascular effects will be evaluated during treatment through routine 12-lead electrocardiographic (ECG) monitoring. The pharmacokinetic relationship between plasma concentration of ofatumumab and its effect on QTc interval duration will be examined. Specifically, ECG assessments will be collected in triplicate at baseline, at the time of maximum ofatumumab concentrations periodically on-therapy, and at the end of treatment. After completion of the final ofatumumab infusion, subjects will continue to be followed for safety and efficacy for six months relative to the last ofatumumab dose.

Ofatumumab/Methylprednisolone Followed by Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) [Recruiting]
The main purpose of this study is to see if the combination of ofatumumab with high dose methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with relapsed or refractory CLL/SLL get rid of their CLL/SLL for a long period of time. Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable.

Phase II Ofatumumab/Methylprednisolone Followed by Ofatumumab/Lenalidomide for Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) [Recruiting]
The main purpose of this study is to see if ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with Chronic Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable.

more trials >>

Reports of Suspected Arzerra (Ofatumumab) Side Effects

Infusion Related Reaction (11)Neutropenia (11)Febrile Neutropenia (9)Diarrhoea (6)Pyrexia (5)Neuropathy Peripheral (5)Dyspnoea (5)Chills (4)Pneumonia (4)Lymphadenopathy (3)more >>


Page last updated: 2014-12-13

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