Latin American Real-world Study in Acute Leukemia
Acute Myeloid LeukemiaAcute Lymphoid LeukemiaThe objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.
CAR T Cell Therapy Related Cardiovascular Outcomes
Cardiovascular DiseasesB-cell Acute Lymphoblastic Leukemia6 moreThis will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.
Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia
Precursor Cell Lymphoblastic Leukemia-LymphomaImproved understanding of the long-time healthcare utilisation of childhood cancer survivors is relevant as it can be seen as a proxy for the population's morbidity. The investigators will conduct a historic population-based matched cohort study using Danish nationwide registry data. Eligible children are children 1.0-17.9 years diagnosed with Acute lymphoblastic leukaemia (ALL) in Denmark from 1994 till 2016. The primary outcome is yearly contact rates to primary healthcare.
Renal and Hepatic Clearance Following High-Dose Methotrexate in Childhood ALL
Lymphoblastic LeukemiaAcute1 moreHigh-dose methotrexate therapy (HDMTX) is an important part of treatment of childhood acute lymphoblastic leukemia (ALL). HDMTX would be improved substantially if it were possible to predict the clearance of MTX for each patient and use this to tailor an individualized dosing of the drug. However, only about 3.7, 0.2, and 2% of the inter-individual variation in MTX clearance is explained by age, gender and ancestry, respectively. Genetic variation seems to explain about 10% of this difference, and SNPs in genes encoding transporter proteins (e.g. organic anion transporter 1B1 (OATP1B1) and reduced folate carrier (RFC)) are suggested to have a particular large impact. A serious limitation to the applicability of SNPs in prediction of MTX pharmacokinetics, however, is the substantial intra-individual variation in MTX clearance. The intra-individual variation in MTX clearance is related to renal function but a large amount of a HDMTX dose also enters the liver, where it is metabolized to 7-hydroxy MTX and probably also undergoes enterohepatic circulation. Thus, the aim of this study is to determine the role of the liver and renal function in MTX pharmacokinetics, and evaluate the predictive potential of pharmacogenetic (e.g. the rfc SNP) and pharmacokinetic parameters of MTX elimination during HDMTX.
Biomarker Study in Bone Marrow Samples From Patients With T-Cell Acute Lymphoblastic Leukemia
LeukemiaRATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with T-cell acute lymphoblastic leukemia.
Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger...
LeukemiaRATIONALE: Testing for minimal residual disease in cell samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment. PURPOSE: This research trial studies a genetic test in identifying previously undetectable minimal residual disease in cell samples from younger patients with acute lymphoblastic leukemia.
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With...
Hematopoietic/Lymphoid CancerAccelerated Phase Chronic Myelogenous Leukemia155 moreRATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV) infection caused by a stem cell transplant. PURPOSE:This clinical trial studies infection prophylaxis and management in treating cytomegalovirus infection in patients with hematologic malignancies previously treated with donor stem cell transplant.
Observational Study of Nelarabine in Children and Young Adults
LeukaemiaLymphoblastic1 moreThis international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).
DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or...
LeukemiaRATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Aerobic and Strengthening Exercise for Acute Leukemia
Acute Lymphoblastic LeukemiaSurvivors of childhood leukemia have muscle weakness and impaired mobility (physical performance), a higher than expected frequency of obesity, and early mortality from cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may complicate physical performance and establish a pattern of sedentary behavior that may lead to a lifetime of inactivity. There is limited evidence that children being treated for leukemia benefit from home exercise programs during the maintenance phase of therapy, particularly in terms of muscle strength and range of motion. However, there are no established guidelines regarding the prescription of exercise for children diagnosed with leukemia. We propose to test the feasibility of an exercise intervention among children being treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate in the exercise intervention will demonstrate improvements in gross motor function, strength, flexibility, and cardio respiratory fitness, and that they will have more favorable body composition when compared to the children who are assigned to the usual activity group.