195 Clinical Trials for Various Conditions
Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Most children and adolescents receive general anesthesia during this procedure to manage pain and anxiety. It is now understood that general anesthesia contributes to impairments in brain functioning in the long term. Therefore, it is important to identify ways to manage pain and anxiety during these procedures that does not include general anesthesia. The investigators propose to test whether virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), used with local anesthesia and the option for an anti-anxiety medication will be an adequate replacement for general anesthesia for participants 7 years of age and over, with ALL in the maintenance phase of treatment.
Acute Lymphoblastic Leukemia, Pediatric
The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.
Acute Lymphoblastic Leukemia, Pediatric
This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children, adolescents, and young adults who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll up to 90 pediatric participants and up to 270 healthy control patients. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.
Acute Lymphoblastic Leukemia, Pediatric
With this research study has following goals * To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated. * To learn more about side effects of palbociclib in combination with chemotherapy; * To learn more about the biological effects of palbociclib on the cells in your body
Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
This project will examine habitual physical activity, bone health, and insulin resistance in pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points: baseline and 6 months. At the two study timepoints, all study participants will be asked to wear an accelerometer, receive a DXA scan of the lumbar spine and hip, and have blood drawn for analysis. Study participants will be given a gift card stipend for each study visit attended. Study visits will coincide with regular office visits to Children's Hospital Oncology Clinic and the Children's Hospital Survivorship Clinics whenever possible. The potential mechanism by which physical activity mediates bone changes will be explored by concurrently measuring changes in lean/fat mass and metabolic status. This pilot study will provide data to inform the design of a randomized controlled trial to test the effect of a physical activity intervention on bone health in PCS.
Acute Lymphoblastic Leukemia, Pediatric, Pediatric ALL, Pediatric Lymphoma, Bone Loss, Metabolic Syndrome, Habitual Physical Activity, Precursor Cell Lymphoblastic Leukemia, Lymphoma, Leukemia, Lymphoid Leukemia, Pediatric, Osteoporosis, Osteoporosis Risk
Music therapy has become a standard palliative care service in many pediatric and adult hospitals; however, a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health, without considering biological dimensions. This study builds on prior work examining the psychosocial mechanisms of action underlying an Active Music Engagement (AME) intervention, designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents, by examining its effects on biomarkers of stress and immune function. The purposes of this two group, randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on child/parent stress during the consolidation phase of Acute Lymphoblastic Leukemia (ALL) treatment. Specific aims are to: Aim 1. Establish whether AME lowers child and parent cortisol during ALL treatment. Aim 2. Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL treatment. Aim 3 (exploratory). Examine the dose-response relationship of AME on child and parent cortisol during ALL treatment. Findings will provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function, with direct implications for the evidence-based use of music to improve health.
Acute Lymphoblastic Leukemia, Pediatric, Pediatric Cancer
The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia.
Acute Lymphoblastic Leukemia, Pediatric, Obesity, Pediatric
Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out the normal blood cells in the bone marrow so that the body cannot make enough normal blood cells. ALL is always fatal if it is not treated. With current treatments, most children and adolescents with this disease will be cured. The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are used, and the doses of the drugs, are similar but not identical for all children and adolescents with ALL. Some children and adolescents receive stronger treatment, especially during the first several months. A number of factors are used to decide how strong the treatment should be to give the best chance for cure. These factors are called "risk factors". This trial is studying the use of a new, updated set of risk factors to decide how strong the treatment will be. The study also will test a new way of dosing a chemotherapy drug called pegaspargase (which is part of the standard treatment for ALL) based on checking levels of the drug in the blood and adjusting the dose based on the levels.
Acute Lymphoblastic Leukemia, Pediatric
The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia
Leukemia, Pediatric
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).
Cancer, Pediatric Cancer, Chemotherapy Effect, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Pediatric, Hematopoietic Stem Cell Transplantation (HSCT)
The survival of children, adolescents and young adults (AYA) with acute leukemia has improved dramatically over the last two decades. This success is a result of using multiple chemotherapy drugs in combination, with the inclusion of drugs that enter the brain and prevent leukemia cells from growing there. Studies in these cancer survivors have shown that the exposure to these chemotherapy drugs can lead to risks for impaired brain function, also referred to as neurocognitive side effects of chemotherapy. There is an opportunity to identify participants at risk for these side effects and to prevent their development. The purpose of this study is to incorporate a brain imaging tool known as Magnetic Resonance Fingerprinting (MRF) to look for brain matter changes in acute leukemia participants receiving chemotherapy. The MRF scan will be performed at diagnosis and repeated at multiple times during the entire therapy duration as well as at defined intervals after therapy is complete. Investigators would also do an electronic test of memory and brain function (cognitive function), which would be administered in a gaming format on iPads or a similar device. The goal will be to correlate results of MRF imaging with the tests of cognitive function. The benefits of this imaging technique include that it can be done quickly (in minutes), it is non-invasive, it is resistant to motion-artifacts and it can be easily repeated for comparison purposes. The advantages of the cognitive test include its short duration of 20 minutes and its gaming format making it friendly for children to use.
Acute Leukemia, Acute Lymphoblastic Leukemia, Pediatric, Acute Myeloid Leukemia in Children, Myeloproliferative Neoplasm
This phase I/II pilot study aims to enhance the effectiveness of stem cell transplant for children and young adults with high-risk acute myeloid leukemia (AML). Patients will undergo a stem cell transplant from a half-matched family donor. One week later, patients will receive an additional infusion of immune cells and a drug called interleukin-2. To mitigate the potential complications associated with graft-versus-host-disease, the donated stem cell product undergoes a process that removes a specific type of immune cell. After transplant, recipients are administered additional immune cells known as memory-like natural killer (ML NK) cells. These cells are derived by converting conventional natural killer cells obtained from the donor. The infusion of a modified stem cell product, along with administration of ML NK cells may help prevent the development of GvHD while simultaneously improving the efficacy of the treatment.
AML, Childhood, Aml, Acute Myeloid Leukemia, Pediatric, Acute Myeloid Leukemia
Phase 1 open-label study to evaluate the safety of intravenously administered, lentivirally transduced T cells expressing anti-CD123 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains in pediatric subjects with relapsed/refractory Acute Myeloid Leukemia (AML).
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, Pediatric, Acute Myeloid Leukemia, Refractory
The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from pediatric and young adult subjects with relapsed/refractory B-cell malignancies (leukemia and lymphoma). Another purpose of this study is to test the safety and cancer killing ability of a cell therapy against a new cancer target (CD22).
B Cell Lymphoma, Acute Lymphoblastic Leukemia, Pediatric, Lymphoma
This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.
Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Pediatric, Acute Lymphoblastic Leukemia
This research study will investigate the effect of two orthotic (brace) devices for the ankle and foot on walking and ankle flexibility in children with cancer not involving the brain or spinal cord.
Gait, Drop Foot, Chemotherapy-induced Peripheral Neuropathy, Acute Lymphocytic Leukemia, Pediatric, Rhabdomyosarcoma, Wilms Tumor
To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated
Leukemia
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients \<18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100 day mortality after this type of transplant will be significantly below the accepted standards, which is about 30% for unrelated donors.
Leukemia
Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate levels during pregnancy, and/or certain variants in the gene that encodes methylenetetrahydrofolate reductase (MTHFR), a key enzyme that catalyzes synthesis of 5-methyltetrahydrofolate \[the primary methyl donor in most metabolic pathways involving methylation including DNA methylation\] from 5,10 methylenetetrahydrofolate may be associated with reduced risks of certain adverse events during the prenatal period, birth weight and certain serious diseases in offspring, while other studies have raised concerns about increased risks of specific serious disorders. Only one study has examined late health effects in mothers that might be associated with use of periconceptional folic acid supplements. We propose to study potential health benefits and adverse effects of periconceptional folic acid supplements in a 15-year follow-up of offspring and mothers. In the offspring, we will evaluate whether periconceptional folic acid supplements reduced risk of external congenital birth defects and childhood acute lymphoblastic leukemia, and whether risks are reduced or increased for other pediatric disorders linked with periconceptional folic acid supplements including asthma, pervasive developmental disorders and autism, diabetes, obesity and blood pressure. In the mothers, we will assess cardiovascular diseases and associated risk factors, breast and colorectal cancers and precursor conditions, and other cancers. We will also conduct exploratory assessment of other serious diseases in mothers. To increase the limited data on the morbidity and survival of children born with a major birth defect, particularly in low- or middle-income countries, we plan to assess morbidity and mortality outcomes in children identified with neural tube defects as part of our follow-up. The women and children who participated in the joint China-U.S. Community Intervention Program (CIP) trial (N=243,779 women treated or not treated with folic acid in the periconceptional period and their offspring) represent unique cohorts whose periconceptional exposure to folic acid is well documented. We propose to follow a sample of 22,000 CIP mothers and their offspring (currently 14 to 17 years of age), to ascertain vital status, medical history, and lifestyle habits. The study will clarify whether there are differences with respect to growth, physical development during the puberty period, selected serious morbidity and mortality in offspring and risks of serious health outcomes and mortality in mothers associated with periconceptional folic acid supplements. Data from this study will inform us about cohort participation rate, cost, and effective approaches for future follow-up of the full cohort. The current protocol focuses on a pilot study (Pilot Study # 1) in which we will carry out two specific aims in 500 families. We will test and evaluate the most effective approaches to trace the mothers who enrolled in the CIP in 1993-1995 in CIP counties, fathers, and children. If the child is not living with the biological mother, we will trace the caretaker or next of kin with whom the child is living. We will also conduct in-person interviews, obtain anthropometric and blood pressure measurements and determine cohort participation rate in a sample of 500 CIP families from two of the 21 CIP project counties to obtain health information, medical history, and vital status. We will attempt to enroll in the pilot study 500 mothers/caretakers and 500 offspring, and 500 fathers (Total N=1500). Excluded from the Pilot Study #1 at this time are the families in which the mother or the child is deceased. We will seek permission from the IRB to enroll these families at a later date.
Pediatric Leukemia, Other Pediatric Cancers
The human microbiome is composed of unique groups of microorganisms occupying distinct habitats distributed throughout the human body. The Human Microbiome Project recently evaluated the bacterial composition of the microbiome in 18 (for women) and 15 (for men) body sites. Much initial attention in the field of microbiome research has focused on the bacterial contribution to a "healthy" microbiome. However, it is clear that other microorganisms, including fungi and viruses, are also distributed throughout the human body and serve as functional components of the microbiome. The populations of microorganisms residing within the oral and nasal cavities make important contributions to human health and disease. These contributions may be especially important in immunosuppressed patients, including those patients receiving myelosuppressive chemotherapy or undergoing hematopoietic stem cell transplantation. In these patients, organisms typically considered as commensals can become pathogenic, either locally or systemically. This observational study is primarily undertaken to evaluate the oral and nasal microbiota and to define the population of fungal organisms residing within the oral and nasal cavities in pediatric oncology patients before and after receiving protocol-directed chemotherapy and associated supportive care.
Acute Myeloid Leukemia, Hematologic Malignancy, Bone Marrow Transplantation
The goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation (HSCT).
Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome
Background: Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. It occurs when a bone marrow cell develops errors in its DNA. Certain tests are used to help detect the disease. But the results of these tests often disagree. Researchers want to review the results of tests of bone marrow and cerebrospinal fluid (CSF) from people with ALL. They want to try to find the best ways to detect the disease. Objective: To compare results of certain bone marrow and CSF tests for detecting ALL, in order to see how much and how often the results disagreed. Eligibility: Children and young adults with ALL or lymphoblastic lymphoma who were enrolled in certain previous studies and consented for their data to be used. Design: Investigators will review participants medical records. They will collect data like the participant s gender, age, and when their tests were done. They will also collect results from tests like: Bone marrow tests Flow cytometry tests Imaging CSF cell count All of the stored data will be labeled by a code that only the study team at the research site can link to the participant. Data will be stored in password protected computers. ...
Leukemia, Lymphoblastic, Acute, ALL, Childhood
This randomized pilot phase II trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of being tired caused by cancer, may help improve strength, and may help build up lost muscle tissue. Nutritional intervention plus exercise intervention may be effective at preventing metabolic syndrome.
Childhood Acute Lymphoblastic Leukemia in Remission
This study is for patients 2-21 years old who have acute leukemia that has not responded well to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study of AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard pre-transplant conditioning regimen (total body irradiation, etoposide and cyclophosphamide). The conditioning regimen is the treatment that is given just before the transplant. This treatment kills leukemia cells as well as healthy bone marrow and immune cells. Researchers want to learn more about how AMD3100 affects acute leukemia cells. Blood and bone marrow samples from study participants will be collected to find out if AMD3100 is making patients' cells more sensitive to the conditioning regimen and to find out how it does this. The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that three doses do not significantly increase the side effects of transplant conditioning, the investigators will give a second group of six patients five daily doses.
Pediatric Acute Myeloblastic Leukemia, Relapsed, Pediatric Acute Lymphoblastic Leukemia, Relapsed
This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.
Leukemia, Solid Tumors
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Myelogenous Leukemia (AML.)
Leukemia, Myelocytic, Acute, Pediatric