Active clinical trials for "Leukemia, Myeloid, Acute"

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 II trial will test whether the Hedgehog signaling pathway inhibitor PF-04449913 can decrease disease relapse in high-risk patients with acute myeloid leukemia after donor stem cell transplant.

This research study is a Phase I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. As part of this research study, you will take alisertib in combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for your cancer. However, cytarabine and idarubicin have both been approved by the FDA for treatment of AML. It also means that the FDA has not approved giving alisertib with idarubicin and cytarabine for use in patients, including patients with your type of cancer. Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest that alisertib may slow down the spread of your cancer. It does this by blocking certain substances needed by the cancer cells to spread. In this study, researchers would like to combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if it can be given safely with chemotherapy in individuals with AML. The primary purpose of this research study is to determine the highest dose that alisertib can be given with idarubicin and cytarabine without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.

Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.

The main purpose of this study is to determine the safety of combining selinexor with daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin and cytarabine will also be established.

This Phase 1b study will determine the maximum tolerated dose of KX2-391 given as a once-daily dose, in elderly patients with acute myelogenous leukemia.

The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy after treatment with an allogeneic stem cell transplant.

The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.

This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria. The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD. Sample size: 440 patients The treatment duration of an individual patient is between 18 and 24 months. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance and follow-up period: Maximum 8 years

An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.