NEWS HIGHLIGHTSMedia Articles Related to Mozobil (Plerixafor Subcutaneous)
Co-Founder Of Microsoft Diagnosed With Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.17]
Paul Allen who co-founded the computer giant Microsoft with Bill Gates in the 1970s has been diagnosed with Non-Hodgkin's Lymphoma, 25 years after surviving Hodgkin's lymphoma. The news was announced in a memo to the staff of Allen's company Vulcan, by CEO Jody Allen, who is also Paul Allen's sister. A copy of the memo was also sent to the media.
FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.12]
The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.
Istodax Approved for Cutaneous T-Cell Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2009.11.09]
Title: Istodax Approved for Cutaneous T-Cell Lymphoma
Category: Health News
Created: 11/6/2009 4:10:00 PM
Last Editorial Review: 11/9/2009
FDA Approves Gloucester Pharmaceuticals' ISTODAX(R) For Patients With Cutaneous T-cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.06]
Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response.
Approved Lymphoma Drug Shows Promise In Early Tests Against Bone Cancer
Source: Bones / Orthopaedics News From Medical News Today [2009.11.06]
A drug already approved for the treatment of lymphoma may also slow the growth of the most deadly bone cancer in children and teens, according to an early-stage study published online in the International Journal of Cancer. The study drug, Bortezomib, was found to be effective against bone cancer in human cancer cell studies and in mice.
Published Studies Related to Mozobil (Plerixafor Subcutaneous)
The AMD3100 story: the path to the discovery of a stem cell mobilizer (Mozobil). [2009.06.01]
AMD3100 was found to inhibit HIV-1 and HIV-2 within the 1-10nM concentration range while not being toxic to the host cells at concentrations up to 500 microM, thus achieving a selectivity index of approximately 100,000. The target of action was initially thought to be the viral envelope glycoprotein gp120...
Plerixafor: in patients with non-Hodgkin's lymphoma or multiple myeloma. [2009]
*The bicyclam plerixafor mobilizes haematopoietic stem cells (HSCs) from the bone marrow into the peripheral blood circulation and augments the effects of granulocyte colony-stimulating factor (G-CSF). *More patients requiring autologous HSC transplantation for non-Hodgkin's lymphoma or multiple myeloma in first or second remission achieved goal increases in mobilized CD34+ cells after subcutaneous plerixafor 240 microg/kg/day for up to four apheresis days in conjunction with a G-CSF treatment regimen than after placebo plus G-CSF...
A phase II study of plerixafor (AMD3100) plus G-CSF for autologous hematopoietic progenitor cell mobilization in patients with Hodgkin lymphoma. [2008.11]
Collection of an adequate number of hematopoietic stem cells can be difficult in patients with relapsed or refractory Hodgkin lymphoma (HL) who are candidates for autologous stem cell transplantation (ASCT). Plerixafor (AMD3100), an inhibitor of the interaction between stromal cell-derived factor 1 (SDF-1) and its receptor CXCR4, is an effective hematopoietic stem cell mobilization agent in patients with multiple myeloma and non-Hodgkin lymphoma (NHL)...
Clinical Trials Related to Mozobil (Plerixafor Subcutaneous)
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant [Recruiting]
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte
colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both
healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected
via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December
2008, Plerixafor received approval from the Food and Drug administration for use in
combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The
proposed study is not designed to support approval of a new indication or change in the
advertising for Plerixafor. The route of administration and dosage level are identical to
that which is listed on the package insert. Although Plerixafor is not approved for
patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of
this drug in this patient population.
The study hypothesis for this study is that patients with a circulating CD34+ count < 20
cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X
10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With De Novo Acute Myeloid Leukemia [Not yet recruiting]
The purpose of this research study is to determine if Plerixafor can release cells into the
blood and make them more sensitive to killing by Cytarabine and Daunorubicin, an anti-cancer
drug regimen referred to as "7+3" that is commonly used in treating acute myeloid leukemia
(AML). In this study, Plerixafor will be added to treatment with Cytarabine and
Daunorubicin. Subjects will be monitored to see how well they tolerate the use of these
drugs together and how well they work to treat the leukemia.
The study is divided into Part 1 and Part 2. The purpose of Part 1 of the study is to find
the highest dose of Plerixafor that can be given safely with Cytarabine and Daunorubicin.
The purpose of Part 2 of the study is to collect additional safety information for
Plerixafor when used with Cytarabine and Daunorubicin to see the effects the combination
treatment has on the subject and his/her leukemia.
A Phase I Study of Mozobil(Trademark) in the Treatment of Patients With WHIMS [Recruiting]
Background:
- WHIMS (warts, hypogammaglobulinemia, infection, and myelokathexis syndrome) is caused
by various genetic changes that increase the activity of the CXCR4 gene. Excessive
function of this gene causes mature neutrophils (part of white blood cells) to be
retained within the bone marrow rather than being released to the general blood
circulation, and is one of the causes of severe inherited neutropenia (low white blood
counts). In neutropenia, the body is less able to fight off infection. Patients with
WHIMS usually are at risk for skin, soft tissue, sinus, and lung infections, which can
result in loss of hearing, teeth, and lung function.
- Current treatment for WHIMS consists of regular injections of a white blood cell growth
stimulating medication called granulocyte colony stimulating factor (G-CSF), and
monthly infusions of intravenous immunoglobulin (IVIG). These therapies are expensive,
nonspecific, have significant side effects and toxicities, and do not fully correct all
problems, especially warts and cancers related to human papillomavirus (HPV).
- A drug called Mozobil(Trademark) has been approved for use in combination with G-CSF to
increase the number of stem cells that can be collected prior to bone marrow
transplantation. Mozobil(Trademark) may offer a specific and well-tolerated new
treatment for WHIMS and other syndromes characterized by neutropenia.
Objectives:
- To evaluate whether Mozobil(Trademark) is safe and effective to treat neutropenia (low
white blood cell count) in patients with WHIMS.
- To determine an appropriate treatment dose of Mozobil, within currently approved dosage
levels.
Eligibility:
- Individuals between 18 and 75 years of age who have been diagnosed with WHIMS and have a
history of severe infections.
Design:
- Potential participants will undergo a screening study, with a medical history, physical
examination, questionnaire, heart and lung function scans, and blood and urine samples.
Tests will also be done for hepatitis B and C virus, and human immunodeficiency virus
(HIV) that causes acquired immunodeficiency syndrome (AIDS), as well as to check
neutrophil function.
- Patients who are being treated with G-CSF will stop injections for 5 days before being
admitted to the National Institutes of Health (NIH) Clinical Center. While off the
medication, patients will keep a diary to report information about their general
well-being while off the medications and will brin...
Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma [Recruiting]
The purpose of this research study is to determine the safety of plerixafor and bortezomib,
and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma
cells from attaching to bone marrow and has been used in other phase I studies for
mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the
combination of plerixafor and bortezomib is very effective in killing myeloma cells in the
laboratory more than the effect of each drug alone.
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia [Not yet recruiting]
This study is designed to test the combination of Plerixafor with G-CSF for
chemosensitization in patients with relapsed or refractory AML.
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