Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid LeukemiaThis is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.
Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic...
Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma2 moreCLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.
Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation...
Myelodysplastic SyndromeAcute Myeloid LeukemiaThe study's primary objective is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of Panobinostat when administered within 150 days after hematopoietic stem cell transplantation (HSCT) and given in conjunction with standard immunosuppressive therapy after HSCT for patients with high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Secondary objectives are To determine safety and tolerability of panobinostat To determine overall and disease-free survival at 12 months after HSCT To evaluate immunoregulatory properties of panobinostat To evaluate patient-reported health-related quality of life (HRQL) The hypothesis of this study is that panobinostat can be an effective drug in preventing relapse of MDS and AML patients with high-risk features after hematopoietic stem cell transplantation with reduced-intensity conditioning (RIC-HSCT) while at the same time reducing graft-versus-host disease (GvHD) with preservation of graft-versus-leukemia (GvL) effect.
Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)
Acute Myelogenous LeukemiaThe purpose of this non-inferiority study is to compare the effectiveness of two induction chemotherapy regimens (cytarabine plus idarubicin [AI] versus cytarabine plus high-dose daunorubicin [AD]) in AML. The effectiveness will be evaluated in terms of complete remission (CR) rate.
PR104 in Treating Patients With Refractory/Relapsed Acute Leukemia
Acute Myelogenous LeukemiaAcute Lymphocytic LeukemiaThe current understanding of PR104 justifies the evaluation of PR104 in subjects with relapsed/refractory AML and ALL. These include: Hypoxia. Leukemic bone marrow is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. Myelotoxicity as the primary toxicity at MTD. In prior clinical studies in subjects with solid tumors PR104 has demonstrated myelotoxicity as the primary toxicity. This observation suggests that PR104 will exert a similar effect on leukemic cells. AKR1C3. AML has been reported to exhibit high levels of AKR1C3 which should lead to selective activation of PR104 within both hypoxic and oxic leukemic cells. Preclinical data. PR104 has demonstrated impressive activity in an initial study using primary human ALL in a mouse model. The initial dose finding phase of the study will provide estimates of the activity and toxicity of PR104 in subjects with refractory/relapsed AML, and determine the optimal individualized dose to give each subject based on his/her covariates (prior CR duration, prior number of salvage therapies, age). Once a potentially beneficial dose has been determined, an expanded cohort of subjects with AML or ALL will receive PR104 at a uniform dose. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity and acceptable safety in AML to warrant future phase II or phase III studies in this indication. Primary objectives Determine the toxicities and recommended dose of PR104 when administered IV to subjects with relapsed/refractory AML and ALL. Secondary objectives Evaluate the pharmacokinetics (PK) of PR104 and a series of PR104 metabolites Evaluate any anti-tumor effects of PR104 Evaluate the expression of AKR1C3 in bone marrow and leukemic cells Evaluate potential biomarkers of hypoxia
Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia
Acute Myeloid LeukemiaThe main goal of this study is to assess the safety and tolerability of RAD001 in combination with low-dose cytarabine in acute myeloid leukemia patients unfit for intensive chemotherapy. The secondary goals are to investigate the likely causes of drug response or failure.
A Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy...
Myelodysplastic SyndromeChronic Myelomonocytic Leukemia1 moreIn this trial, the investigators will test the combination of escalating doses of chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major toxicity in comparison to historical results obtained with chemotherapy alone in the same subset of patients.
Effectiveness of Protected Environment Rooms for AML and MDS
Acute Myelogenous LeukemiaMyelodysplastic SyndromeThe goal of this clinical research study is to learn if the "protected environment" (PE) can help to prevent infections in patients aged 60 and above who are receiving what is considered low-intensity treatment for newly-diagnosed AML or high-risk MDS.
Chemotherapy, Interferon, and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous...
LeukemiaRATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia.
Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
LeukemiaMyelodysplastic SyndromesRATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.