Eligible subjects will be in this study for 4 weeks and will have the following tests and procedures:
All study participants will be reimbursed with $35 upon completion of the study. The study drug Lisinopril will be provided to you free of charge during the study period.
]]>Subjects will have a 1 in 5 chance of being assigned to one of the following treatment groups. In each of the treatment groups, they will receive either MK-5172 and boceprevir placebo (placebo is a look-alike with no active ingredients, sometimes called a sugar pill) or boceprevir and MK-5172 placebo. Placebo is being used so that all 5 treatment groups look alike.
The purpose of this study is to assess the response to the systematic and simplified, and therefore very teachable, approach we use at the Hypertension Center, that limits treatment to a mere 2 options:
(1) augmentation of the diuretic regimen, and/or
(2) addition of combined alpha/beta blockade
Both options employ drugs that are approved for treatment of hypertension, and at approved dosages. Our preliminary data indicate that RH can be controlled in 80-90% of such patients with this approach. We also intend to collect data on biochemical and psychological variables to determine if they are helpful in predicting which treatment option is more likely to be effective in the individual patient.
]]>The purpose of the study is to evaluate the response to treatment with an experimental drug called ibrutinib, also called PCI-32765.
Ibrutinib is an oral drug that inhibits the enzyme Bruton’s Tyrosine Kinase (BTK), decreasing the ability of lymphoma cells to grow and survive.
All study participants will receive ibrutinib; there is no placebo. Participants will take 4 capsules by mouth once every day. Participants will continue taking ibrutinib as long as they are responding to treatment and not experiencing unacceptable side effects.
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The purpose of the study is to determine if cabozantinib is effective in prolonging survival compared to the drug prednisone. The study will also evaluate the safety of cabozantinib and how well people with advanced prostate cancer tolerate the drug. In an ongoing study, cabozantinib treatment has resulted in high rates of pain relief and has shown substantial anti-tumor activity. Cabozantinib could provide a valuable new treatment option for men with CRPC who experience disease progression on or after prior therapies.
Study participants will be randomly assigned to one of two treatment groups:
Group 1: cabozantinib once daily + placebo prednisone twice daily
Group 2: Prednisone twice daily + placebo cabozantinib once daily
Participants have a 2/3 chance of receiving cabozantinib (Group 1) and a 1/3 chance of receiving prednisone (Group 2). Participants will not know which treatment they are receiving. Cabozantinib is a capsule and prednisone is a tablet, both taken by mouth.
Participants will continue to receive study treatment as long as they continue to receive clinical benefit and do not experience unacceptable side effects.
The study is evaluating an experimental drug called ibrutinib (also known as PCI-32765). Ibrutinib is a type of drug called a kinase inhibitor; the drug blocks an enzyme that helps cancer cells live and grow. By blocking the enzyme, it is possible that ibrutinib will kill cancer cells or stop them from growing.
The purpose of the study is to determine whether ibrutinib is safe and effective in treating CLL/SLL with 17p deletion.
All study participants will receive ibrutinib; there is no placebo in this study. Participants will take 3 capsules by mouth once a day and continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.
]]>The purpose of this study is to follow people after their transplant to better understand the onset and course of GVHD after stem cell transplant.
Participants will be in the study for at least 2 years after their transplant. There are 5 study visits; however, participants who get GVHD will have up to 7 additional visits.
]]>Aspiration Therapy reduces the calories absorbed by the body, allowing a person to drain a portion of his/her stomach contents after a meal. The device includes:
Placement of the A-Tube will be performed as an outpatient endoscopic procedure (no overnight stay), using consious sedation. The procedure takes about 30 minutes and will be performed at NewYork-Presbyterian Hospital by the study gastroenterologist.
To perform Aspiration Therapy, about 20 minutes after eating each major meal of the day, participants will remove (aspirate) a portion of the food eaten by emptying the stomach contents. Because only about half the calories eaten are removed, the body still receives the calories it needs to function.
Study participants will be randomly assigned to one of two treatment groups:
Participants have a two-thirds chance of being enrolled in the Aspriation Therapy Group and a one-third chance of being enrolled int he Lifestyle Therapy group. Participants in both groups will receive lifestyle therapy, which will include 10 sessions with a registered dietician.
The study will last for 1 year, during which there will be 14 to 16 visits, depending on the group. Participants enrolled in the Aspiration Therapy group will have the option of extending their participation to 5 years.
Participants will be compensated $75 for each visit, starting at the 2nd visit, and they will be compensated $125 for the year 1 visit.
]]>The purpose of the study is to compare the effectiveness of adding either the drug lenalidomide or the drug vorinostat to the regular drug azacitidine in treating MDS or CMML.
Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.
Study participants will be randomly assigned to one of three treatment arms:
Arm 1: Azacitidine and lenalidomide
Arm 2: Azacitidine alone
Arm 3: Azacitidine and vorinostat
Participants will take the study medication(s) for as long as they are responding to treatment.
]]>Elotuzumab is a manufactured protein directed against a target on multiple myeloma cells. In laboratory studies elotuzumab was found to kill myeloma cells.
All patients in this study will receive elotuzumab. There is no placebo. In this study a treatment is cycle is 28 days. Patients will receive elotuzumab via infusion:
Treatment will continue until disease progression or if a patient has unacceptable side effects. In addition patients will receive medications to prevent fevers or other allergic reactions before each elotuzumab dose.
]]>The purpose of this study is to determine the effectiveness of treating DLBCL with the experimental drug fostamatinib. The study will also evaluate the side effects of fostamatinib when used to treat DLBCL.
Fostamatinib inhibits an enzyme called spleen tyrosine kinase (Syk). Lymphoma cell multiplication and survival is linked to this enzyme. It is possible that by inhibiting the Syk enzyme, fostamatinib may inhibit and eliminate lymphoma cells.
All study participants will take fostamatinib 200 mg pill by mouth twice daily; there is no placebo.
Study participants may continue with fostamatinib treatment as long as they are receiving benefit and do not experience unacceptable side effects.
]]>The purpose of the study is to evaluate the safety and effectiveness of brentuximab vedotin before autologous hematopoietic stem cell transplant.
Brentuximab vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs have 2 parts: a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). Antibodies can attach to and attack specific targets on cells. The antibody part of brentuximab vedotin attaches to an important target on Hodgkin Lymphoma cells. The chemotherapy part of brentuximab vedotin kills cells to which the antibody part of the drug attaches.
Study participants will receive brentuximab vedotin via infusion once every 21 days for 4 cycles (12 weeks).
]]>The purpose of the study is to confirm the effectiveness of the experimental drug CPX-351 as a first line therapy for high risk (secondary) AML in older people, compared to the currently used combination treatment (“7+3”).
CPX-351 is a combination of two anti-tumor drugs, Cytarabine and Daunorubicin. This study will use a “liposome” injection; this is a fat capsule (liposome) that surrounds the Cytarabine and Daunorubicin and protects the drugs from being eliminated/destroyed by the body.
7+3, the currently used combination treatment, also combines Cytarabine and Daunorubicin. It is called 7+3 because people receive 7 days of continuous infusion of Cytarabine and infusions of Daunorubicin on days 1, 2 and 3.
Study participants will be randomly assigned to one of two treatment arms:
Participants may be treated with up to 2 induction cycles of CPX-351 or 7+3. If a participant’s disease is in remission after two induction cycles, he/she may receive up to 2 more treatment cycles (consolidation therapy).
Once treatment is completed, participants will have follow-up visits once a month for a year after starting the study, and then will be followed for up to 5 years after entering the study.
]]>Some people with AML have a gene mutation called FLT3-ITD. Quizartinib is designed to block the FLT3 receptor on leukemia cells. This may slow or stop leukemia cell division and may lead to leukemia cell death. The drug may also work against other receptors that are involved in leukemia cell division and growth.
Participants will be randomly assigned to one of two doses of Quizartinib (30 mg or 60 mg).
Quizartinib is a liquid taken by mouth. Study participants will take daily doses of the drug.
]]>The purpose of this research study is to determine if a once daily dose of SAR302503 is effective in treating men and women with myelofibrosis who were previously treated with ruxolitinib.
SAR302503 is an experimental compound being developed as an orally available treatment for myelofibrosis. SAR302503 acts on a substance in blood cells; the substance is related to the genetic marker called JAK2, which is found in many patients with myelofibrosis.
All study participants will receive SAR302503; there is no placebo. There is a 6-month, 6-cycle treatment period. Participants will take the study drug by mouth once daily in consecutive 28-day cycles.
Participants who continue to benefit clinically will be allowed to remain on SAR302503 beyond the 6-month treatment period as long as they tolerate the medication.
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