Early Tapering of Immunosuppressive Agents to Immunomodulation to Improve Survival of AML Patients...
Acute Myeloid LeukemiaDisorder Related to Bone Marrow TransplantationEarly reduction of immunosuppressive agents after HLA matched donor transplantation can improve the survival of advanced stage acute myeloid leukemia. single-center, open clinical study
High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML
LeukemiaMyeloidThe purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia(AML).
Randomized Study: Standard of Care With or Without Atorvastatin for Prevention of GVHD for Matched...
Acute Myeloid LeukemiaAcute Lymphocytic Leukemia1 moreChronic Graft Versus Host Disease (GVHD) is one of the most challenging complications in long term survivors of allogeneic stem cell transplantation. As the number of allogeneic stem cell transplantations rises annually, the incidence of chronic GVHD rates have also increased due to a variety of factors including but not limited to increasing use of peripheral blood stem cell (PBSC) grafts, increasing age of both donors and recipients, and increased use of matched unrelated donors. One study showed much lower than traditional acute GHVD rate and chronic GHVD which is similar with historical rates when atorvastatin was administered prophylactically to both the donors as well as recipients of matched related allogeneic stem cell transplantation, lead to the interest in further examining the role of Atorvastatin in relation to the development of GVHD. The investigator hypothesize that the administration of atorvastatin in recipients of matched unrelated allogeneic stem cell transplantation, a group with known higher incidence of chronic GHVD, would be a safe and effective method to reduce the incidence of chronic GVHD. Matched related allogeneic stem cell transplantation recipients will not be included in this study due to their significantly lower GVHD rates. The definition and monitoring of our primary endpoint of GVHD is well established in clinical trials in allogeneic stem cell transplantations and the investiagor will utilize the National Institutes of Health (NIH) Staging System for the diagnosis and severity assessment of chronic GVHD as well the recommendations from the NIH Consensus Conference for the conduct of clinical trials in chronic GVHD. Several secondary endpoints will be examined as defined below and include standard complementary data in the examination of clinical trials in chronic GVHD again as laid out by the NIH Consensus Conference for conduct of clinical trials in chronic GHVD.
The Effects of AMPC in the Treatments of Refractory or Relapsed AML
Acute Myeloid Leukaemia RecurrentA private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
Chronic Myelogenous LeukemiaOur goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.
The Efficacy and Safety of Induction-Maintenance Protocol for Patients With Chronic Myelogenous...
Chronic Myeloid LeukemiaPhiladelphia Chromosome Positive CMLThe purpose of this pilot study is to investigate whether some patients who were started on a 2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI, while maintaining or even deepening the molecular response as a cost-effective treatment. Eligible patients will be switched to imatinib 400mg daily, with regular molecular monitoring.
Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and...
Myelodysplastic SyndromesAcute Myeloid Leukemia1 moreIt is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow (BM) partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).
Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for...
Chronic Myeloid LeukemiaLeukemia3 moreA multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability, safety, pharmacokinetics and preliminary efficacy of PF-114 for oral administration in adult patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), which is resistant to the 2-nd generation Bcr-Abl inhibitors or has T315I mutation in the BCR-ABL gene.
Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients...
Pulmonary Aspergillosis - InvasiveAcute Myeloid LeukemiaThis study assesses the pharmacokinetics and safety of the new antifungal F901318 in AML patients.
Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors (TKIs) in Chronic Phase...
LeukemiaMyeloid1 morePatients will be randomized in phase II trials to continue on the same TKI versus one of the alternative treatment approaches. If a patient is not eligible for one of the treatments, he (she) will be randomized between the options for which he (she) is eligible. The trial will start with current available treatment options (experimental arms). New available treatment options may be open at any times later on. Authorized TKIs are imatinib, nilotinib, dasatinib, bosutinib and ponatinib. For all options the treatment duration is for a minimum of 12 months and will be continued in the absence of adverse events following investigator decision. Each therapeutic option will be detailed in term of combination modalities, dose, dose adaptation, specific warnings, specific exclusion and inclusion criteria. The decision to introduce a new option will depend on the general pace of recruitment and on the assessment of the potential efficacy and safety of the new treatment, and will be implemented after scientific review by a protocol amendment. Primary objective: A. To select molecules in combination or sequentially with imatinib, nilotinib, dasatinib, bosutinib or ponatinib potentially able to produce a 25% increase in the Cumulative Incidence of MR4.5 as compare to control. Secondary objectives: A. To determine the safety of selected therapies B. To determine the rate of MR4 by 12, 24, 36, 48 months in experimental and control arms C. To determine the rates of MR4.5 by 24, 36, 48 months in experimental and control arms D. To determine the rate of undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies) by 12, 24, 36, 48 months in experimental and control arms E. To estimate treatment free remission (TFR) in patients eligible for discontinuation studies F. To investigate the relationship between biological activity and the clinical efficacy of the selected therapies G. To assess the effects of the treatments on the number and clonogenicity of CML stem cells and other biological markers of interest H. To estimate duration of response, progression-free survival, event free survival and overall survival.