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In preclinical studies Pevonedistat has shown significant single agent activity against mouse xenograft models of AML cell Line HL-60. Also this effect seemed to be synergistically enhanced by combining it with Azacitidine. In clinical arena, Pevonedistat has shown single agent activity in heavily
The active metabolite of SGI-110 (2'-deoxy-5-azacytidylyl-(3'→5')-2'-deoxyguanosine sodium salt), a dinucleotide, is decitabine, an FDA-approved agent for the treatment of myelodysplastic syndromes. SGI-110 is resistant to modification by cytidine deaminase, a common pathway of decitabine metabolism
INTRODUCTION 1.1 Background Myelodysplastic syndrome (MDS) is characterized by deficiencies in blood cell production that can lead to anemia, which may necessitate regular transfusions of red blood cells (RBCs) as supportive therapy. While this treatment can be life-saving, since the body has no
Describe succinctly and clearly the past findings which justify the plan for this project. A summary of the relevant literature in the area of interest and reports of previous studies should be included.
For majority of lymphoma patients who relapse after complete response or who are primary
Study Drug Administration:
If you are found to be eligible to take part in this study, on Days 1-4 of every cycle, you will receive azacitidine by vein over 15-30 minutes.
You may receive drugs to help prevent nausea and vomiting before you receive your dose of azacitidine.
On Days 5-7 of every
Rationale: Graft-versus-host disease (GVHD) remains a major cause of morbidity and mortality after allogeneic HSCT. The combination of a calcineurin inhibitor and methotrexate has been the standard GVHD prophylactic regimen for the past 20 years. However, the incidence of acute GVHD remains high,
Hematopoietic stem cell transplantation (SCT) is an effective treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). For patients transplanted in first remission or with low risk MDS, approximately 60% of patients have achieved long-term disease free survival. Patients with
In the United States, the incidence of acute myeloid leukemia (AML) is approximately 3.5 cases per 100,000 persons per year. Approximately 13,000 people were diagnosed with AML in 2009 and 9,000 died of the disease, making AML the 6th leading cause of cancer death. Over the past three decades, AML
This is a three-part phase 1 study in which nineteen to one hundred two patients with Low, Intermediate-1, Intermediate-2, or High risk MDS will receive oral doses of ON 01910.Na Concentrate as escalating single or multiple doses (70mg to 700 mg bid) up to 14 days of a 21-day cycle.
Part I:
The Study Drugs:
Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.
Lenalidomide is designed to change the immune system. It may also interfere with the development of
Chemotherapy-related nausea and vomiting is a frequent problem among patients with leukemia that can lead to further medical problems, such as malnutrition, dehydration, electrolyte imbalance, and a lower quality of life. Cytarabine, one of the drugs that is used to treat AML and high-risk MDS, is
The Study Drugs:
Gemtuzumab ozogamicin is designed to attach to Sialic acid-binding Ig-like lectin 3 (CD33), a certain protein that is often found in leukemia cells, causing them to die.
Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to
Cytarabine is a drug that is used to treat AML and high-risk MDS. It is known to cause nausea and/or vomiting. All patients that receive cytarabine also receive drugs to help prevent these side effects.
The Study Drugs:
Ondansetron is designed to block the action of serotonin, a substance in the
The Study Drugs:
Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Vorinostat is designed to cause chemical changes in different groups of
The Study Drugs:
Gemtuzumab ozogamicin is designed to attach to Sialic acid-binding Ig-like lectin 3 (CD33), a certain protein that is often found in leukemia cells, causing them to die.
Decitabine is designed to damage the Deoxyribonucleic acid (DNA) (the genetic material) of cells, which may cause