New Clinical Trial: Randomized, Open Label, Phase 2 Study of Selinexor (KPT-330) vs Physician’s Choice in Patients Greater Than or Equal to 60 Years Old with Relapsed/Refractory Acute Myeloid Leukemia (AML) who are Ineligible for Intensive Chemotherapy and/or TransplantPosted: November 12, 2014
The Weill Cornell Leukemia Program has recently opened a new clinical trial for men and women who have been diagnosed with Acute Myeloid Leukemia (AML). The study sponsor is Karyopharm Therapeutics and the principal investigator at Weill Cornell is Dr. Gail Roboz. For more information about the study, please call Tania Curcio, RN at (212) 746-2571 or e-mail firstname.lastname@example.org.
- Men and women age 60 and older with a confirmed diagnosis of AML
- Previously treated with at least one prior therapy
- Have not undergone and currently ineligible for stem cell transplant and/or intensive chemotherapy
- Have not been diagnosed with Acute Promyelotic Leukemia (AML M3), Chronic Myeloid Leukemia (CML), and Central Nervous System Leukemia
- Detailed eligibility reviewed when you contact the study team
This randomized, open label study has been designed to assess whether Selinexor (KPT-330) can improve the overall survival in patients with relapsed or refractory AML who are not candidates for intensive chemotherapy. Selinexor (KPT-330) works by trapping “tumor suppressing proteins” within the cell and thus causing the cancer cells to die or stop growing. The study drug has previously been tested in humans to define a safe dose to be administered. Selinexor is currently being tested in other clinical trials in patients with advanced cancers. This study will examine the effects of Selinexor on AML and the side effects that may occur as a result of treatment. It will also compare the effect of Selinexor with the effect of other existing treatments for AML that your physician can recommend.
Potential subjects will be enrolled in of two treatment groups:
Treatment group 1: In group 1, KPT-330 will be given orally (by mouth) twice weekly
Treatment group 2: In group 2, your physician will choose one of the following AML treatments that are currently available:
- Best supportive care (BSC) including blood product transfusions, antimicrobial drugs, growth factors as needed, and hydroxyurea
- BSC + low dose Ara-C given twice a day by subcutaneous injection
- BSC + hypomethylating agent azacitidine given by subcutaneous injection or decitabine administered intravenously
Selinexor will be given orally twice weekly (Monday and Wednesday or Tuesday and Thursday) at a dose of 60-120 mg
Watch Dr. Gail Roboz’s appearance on Good Morning America with Robin Roberts, where she discusses bone marrow transplants for leukemia and myelodysplastic syndrome (MDS). She also mentions CRUSH!!MDS http://www.crushmds.org/, a comprehensive clinical database initiated by Dr Roboz, M.D. on behalf of the MDS Clinical Research Consortium. The segment with Dr. Roboz starts with 4 minutes left in the video, which can be seen via this link. Photo by Ida Mae Astute/ABC
Dr. Ellen Ritchie Receives $112,200 Contribution to Leukemia Fighters from the Plumbing Industry Promotion Fund of the City of New York and the Association Contracting Plumbers of the City of New YorkPosted: June 3, 2013
An April 21, 2013 article in the New York Times describes the budding field of Precision Medicine. The article highlights Weill Cornell’s state-of-the-art Cancer Center and how Precision Medicine is being used to treat patients with Leukemia. To read the full article, click here.
Leukemia Program Nurse Practitioner, Sandy Allen-Bard, moderated a Medscape Eduation program titled, The Nurse View: Common Clinical Challenges and Best Practices in Chronic Myeloid Leukemia. The view the program (which requires that you create a free Medscape account), click here.
Leukemia & Lymphoma Society Awards $1.8 Million to Weill Cornell for Translational Research in Blood CancersPosted: August 31, 2012
New Translational Research Grants Awarded to Accelerate Promising Blood Cancer Research Discoveries from the Laboratory to the Patients’ Bedside. Read the press release here.
For more information on the Leukemia and Lymphoma Society, click here.
For information on the Guzman Lab and the research of Monica Guzman, PhD, click here.
For information on the laboratory of Dr. Duane Hassane, click here.
Dr. Gail Roboz spoke with ecancertv at ASH 2011 in San Diego about the major genomic research on acute myeloid leukaemia. There has been a lot of recent success on identifying mutations and abnormalities in AML; however, Prof Roboz believes that the discovery period with genomic research is coming to an end and a move towards clinical trials and targeted therapies need to be developed. The largest development has been the role of stems cell in research and how to target the cells that are left over after chemotherapy.
Two NewYork-Presbyterian-Weill Cornell Medical Center patients and their families held a fundraiser on Staten Island to help other patients with leukemia. The patients met when they were receiving treatment at NYP/Weill Cornell.
Click the image below to watch the video on NY1.
Leukemia Program Nurse, Sandra Allen-Bard, contributed to an informational video on Chronic Myeloid Leukemia. To view it, click here.
The work of Drs. Ritchie, Roboz, Scandura, Gergis, and Feldman, and nurse Tania Curcio was presented at the 2009 American Society of Clinical Oncology Annual Meeting. The presentation focused on a clinical trial treating elderly AML and high-grade MDS patients. To view the presentation, click here.