View clinical trials related to Acute Myeloid Leukemia.
Filter by:This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug is effective in treating a specific cancer. "Investigational" means that sulindac is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved the use of sulindac for your type of cancer. Participants in this study must have undergone previous chemotherapy and achieved complete remission, which is the absence of disease activity in people with a chronic illness, in this case AML. Unfortunately, a significant number of patients with AML who achieve a complete remission with initial chemotherapy eventually experience a relapse, often within a few months. Previous research studies have demonstrated that a type of medication frequently used to treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX inhibitors are ibuprofen and naproxen. For this study, the investigators are using a COX inhibitor called sulindac, which has been FDA approved and used to treat pain and inflammation for many years, and has also been studied in suppressing certain tumors of the gastrointestinal system. The main goal of this study is to determine whether sulindac can help participants remain in a state of complete remission following the initial course of chemotherapy for AML, and two cycles of chemotherapy that is standard of care for your cancer, called consolidation chemotherapy. During the course of this study, the investigators will also attempt to learn more about how COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by studying the participants on this trial.
The goal of this clinical research study is to learn if BL-8040 in combination with cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia (AML) that has relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion protein CDX-1401 and decitabine in patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205-NY-ESO-1 fusion protein, called CDX-1401, is a full length NY-ESO-1 protein sequence fused to a monoclonal antibody against DEC-205, a surface marker present on many immune stimulatory cells. This drug is given with another substance called PolyICLC, which acts to provoke any immune stimulatory cells which encounter the NY-ESO-1-DEC-205 fusion protein to produce an immune response signal against NY-ESO-1. Immune cells which have thus been primed to react against NY-ESO-1 may then attack myelodysplastic or leukemic cells which express NY-ESO-1 after exposure to the drug decitabine. The chemotherapy drug decitabine is thought to act in several different ways, first, it may directly kill cancer cells, and secondly, the drug can cause cancer cells to re-express genes that are turned off by the cancer, including the gene for NY-ESO-1. Giving DEC-205/NY-ESO-1 fusion protein (CDX-1401) and polyICLC together with decitabine may allow the immune system to more effectively recognize cancer cells and kill them.
To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation
Primary objective: To determine the efficacy of an induction regimen using decitabine as an epigenetic primer followed by cytarabine in the treatment of older patients with newly diagnosed Acute myeloid leukemia (AML). Primary endpoint: Complete remission rates Secondary objective: To determine the safety of an induction regimen of decitabine followed by cytarabine in the treatment of older patients with newly diagnosed AML, evaluate survival and identify potential predictive factors for response to treatment Secondary endpoints: - Treatment related toxicities - 4 and 8 week mortality - Overall survival - Relapse-free survival - Predictive factors for response to treatment - Quality of Life measures including self reported symptoms and assessment of sleep patterns Treatment administration Induction therapy Eligible patients will be treated with induction therapy (decitabine + cytarabine) at the University of Pittsburgh Cancer Center inpatient leukemia service at Shadyside Hospital. Patients will receive decitabine 20mg/m2 in 100mL normal saline (NS) intravenously (IV) over 1 hour daily for five days, followed by cytarabine 100mg/m2 in 1000 mL normal saline (NS) as a continuous IV infusion over 24 hours for 5 days. Treatment should be discontinued or delayed for any of the following during the treatment period: a rise in serum creatinine > 2x patient baseline or upper limit of normal (whichever is higher) unless there is an identifiable reversible etiology, or ALT, AST or total bilirubin > 5x upper limit of normal, and should be held until resolution below these parameters. There are no parameters for dose reduction. Patients who have persistent disease on post-treatment bone marrow aspirate and biopsy, will undergo a repeat cycle of induction with decitabine followed by cytarabine as outlined above. Supportive care including blood product transfusions, antiemetic medications antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the provider. Maintenance therapy Patients in complete response (CR) will proceed to decitabine maintenance therapy, where each treatment will be decitabine 20mg/m2 in 100mL normal saline (NS) intravenously (IV) over 1 hour daily for five days administered in the outpatient setting. Maintenance treatments will be continued until disease relapse. Maintenance treatments can be administered as an outpatient at the Hillman Cancer Center, or at a University of Pittsburgh Medical Center (UPMC) facility that is able to administer chemotherapy under the supervision of an Oncologist Evaluations during maintenance Phase: During maintenance therapy, complete blood count (CBC) w/ diff/platelets, CMP (Na, K, Cl, carbon dioxide (CO2), glucose, blood urea nitrogen (BUN), Cr, Ca, Total Protein, Albumin, AST, ALT, Alk Phos, Total Bilirubin) will be checked each cycle on day 14 [+/- 4 days]. Within 7 days of start of new cycle, study visits will include physical exam, adverse events assessment, CBC and comprehensive metabolic panel (CMP). Maintenance cycles will be 28 days [+/- 7 days]. Cycles can be held up to 4 weeks [28 days]. For start of new cycle, any grade 3 or 4 non-hematologic toxicity possibly, probably or definitely related to decitabine therapy must resolve to grade 2 or baseline. In addition the following lab parameters must be met to start a new cycle of maintenance: Absolute Neutrophil Count (ANC) > or = 1000/mm3 Platelets >/= 50,000/mm3 AST or ALT < 2 x Uppler Limit of Normal (ULN) Total billirubin < 2 x ULN Serum creatinine < 2x patient baseline or upper limit of normal (whichever is higher) [If lab parameters are not met for start of cycle, these labs will be checked a minimum of once per week]. If start of new cycle is held for more than 4 weeks [28 days], the subject will be off treatment. Other reasons for delay in treatment should be discussed with the Principal Investigator.
This phase I/II trial studies the side effects and best dose of donor natural killer cells when given together with donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies that are likely to come back or spread. Giving chemotherapy, such as busulfan and fludarabine phosphate, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen. If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft. 6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated. The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.
The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy.
This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.