NEWS HIGHLIGHTSMedia Articles Related to Arzerra (Ofatumumab)
Data show new Roche leukemia drug may improve on Rituxan
Source: Yahoo! Health News [2013.05.16]
By Bill Berkrot (Reuters) - An experimental leukemia treatment that Roche Holding AG hopes will improve upon its best-selling cancer drug Rituxan delayed disease progression twice as long as chemotherapy, according to preliminary trial data releas...
Possible New Acute Leukemia Marker Treatment Target Identified
Source: Genetics News From Medical News Today [2013.05.15]
A study has identified microRNA-155 as a new independent prognostic marker and treatment target in patients with acute myeloid leukemia that has normal-looking chromosomes under the microscope (that is, cytogenetically normal acute myeloid leukemia, or CN-AML). The study was led by researchers at the Ohio State University Comprehensive Cancer Center - Arthur G...
Drug Combo Looks Promising For Chronic Lymphocytic Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.15]
Doctors at Dartmouth-Hitchcock's Norris Cotton Cancer Center (NCCC) have found a combination of drugs to potentially treat chronic lymphocytic leukemia (CLL) more effectively. The research was published online recently, and it will appear as a letter in the journal Leukemia, a publication of the prestigious Nature Publishing Group. The study helps address a basic problem of treating CLL...
Leukemia Drug Prevents Build-Up Of Toxic Brain Protein
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.14]
Researchers at Georgetown University Medical Center have used tiny doses of a leukemia drug to halt accumulation of toxic proteins linked to Parkinson's disease in the brains of mice. This finding provides the basis to plan a clinical trial in humans to study the effects...
Genetic Test Identifies Two Types Of Leukemia; Discovery Provides Insights Into New Treatment Approach
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.14]
Research method used by scientists with the Knight Cancer Institute at Oregon Health & Science University shows promise in accelerating advances in personalized cancer medicine Patients with two forms of leukemia, who currently have no viable treatment options, may benefit from existing drugs developed for different types of cancer, according to a study conducted by research...
Published Studies Related to Arzerra (Ofatumumab)
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.
Rituximab, ofatumumab and other monoclonal anti-CD20 antibodies for chronic
lymphocytic leukaemia. [2012]
CONCLUSIONS: This meta-analysis showed that patients receiving
Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from
a multicenter study. [2012]
New treatments are required for rituximab-refractory follicular lymphoma (FL). In
the present study, patients with rituximab-refractory FL received 8 weekly
infusions of ofatumumab (CD20 mAb; dose 1, 300 mg and doses 2-8, 500 or 1000 mg;
N = 116)... Ofatumumab was well tolerated and modestly active in this heavily pretreated,
rituximab-refractory population and is therefore now being studied in less
refractory FL and in combination with other agents in various B-cell neoplasms.
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. [2011.12]
OBJECTIVES: To evaluate the efficacy and safety of intravenous ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, active rheumatoid arthritis (RA) patients despite methotrexate treatment... CONCLUSIONS: Ofatumumab significantly improved all clinical outcomes in biological-naive, active RA patients with no detectable immunogenicity at week 24. No unexpected safety findings were identified. Trial Registry clinical trials.gov registration number NCT00611455.
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 and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) [Recruiting]
The purpose of this phase II open label study is to evaluate the safety and efficacy of
ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent
B-NHL who have relapsed after Rituximab treatment. A maximum of 53 subjects at least 18
years old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular
lymphoma; Grades 1, 2 and 3a, will be enrolled (34 in Stage 1 and 19 in Stage 2). Subjects
should have Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete
Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following
completion of therapy or subjects should have relapse or disease progression following
response to prior rituximab-based therapy and with a Eastern Cooperative Oncology Group
(ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on
day 1 of each cycle (cycles 1-6) will be followed by Bendamustine 90 mg/m2 IV on days 1, 2
of each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the
induction phase will receive ofatumumab 1000 mg IV every 2 months for 2 years.
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.
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 >>
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