4SCAR-T Therapy After Anti-CD19 Immunotherapy Targeting B Cell Acute Lymphoblastic Leukemia
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
NCT04430530 — CD19 Negative B-cell Malignancies
Status: Recruiting
http://inclinicaltrials.com/cd19-negative-b-cell-malignancies/NCT04430530/
Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
This is a randomized unblinded Phase II clinical trial evaluating the impact of intensive antihypertensive control (targeted to the 50-75th percentile for age, sex, and height) compared to conventional antihypertensive control (targeted to the 90-95th percentile for age, sex, and height) on the incidence of radiographically extensive osteonecrosis in children and young adults receiving treatment for newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL). Primary Objective - Compare the frequency of radiographically extensive osteonecrosis in patients receiving intensive compared to conventional antihypertensive therapy. Secondary Objectives - Evaluate the efficacy of intensive antihypertensive control compared to conventional antihypertensive control in the prevention of clinically significant (CTCAE Grade 2 or higher) and radiologically extensive osteonecrosis, overall and stratified by joints. - Compare the frequency of clinically significant and radiographically extensive osteonecrosis in patients receiving antihypertensive therapy and historical controls. - Compare blood pressures achieved in intensive and conventional arms using both pressures obtained as part of routine patient care and ambulatory blood pressure monitoring. - Compare levels of vascular dysfunction as measured physiologically, radiographically, and in blood samples in patients receiving intensive compared to standard antihypertensive therapy. Exploratory Objectives - Identify predictive patterns of blood biomarkers which identify patients at high- risk of developing clinically significant osteonecrosis. - Identify MRI findings during late induction which correlate with osteonecrosis lesions seen during reinduction. - Identify patterns of diurnal blood pressure variation as measured by ambulatory blood pressure monitoring associated with the later development of osteonecrosis. - Compare induction blood pressure control and intervention arm to echocardiographic changes at reinduction II. - Evaluate patient-reported, health-related quality of life in patients during induction and after 1.5 years of therapy when many experience the symptoms of osteonecrosis.
NCT04401267 — Hypertension
Status: Active, not recruiting
http://inclinicaltrials.com/hypertension/NCT04401267/
Biologic Mechanisms and Dosing of Active Music Engagement in Children With Acute Lymphoblastic Leukemia and Parents
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.
NCT04400071 — Pediatric Cancer
Status: Recruiting
http://inclinicaltrials.com/pediatric-cancer/NCT04400071/
Phase II Study of Blinatumomab and Concurrent Oral Tyrosine Kinase Inhibitor Therapy as Consolidation and Maintenance Therapy for Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Following Chemotherapy-Sparing Induction
The purpose of this study is to test whether blinatumomab in combination with TKI therapy (such as dasatinib) is an effective treatment for people with Ph+ ALL. Researchers want to improve the response to standard-of-care treatment of corticosteroids + TKI therapy by adding the study drug, blinatumomab.
NCT04329325 — Acute Lymphoblastic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT04329325/
Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia
Background: Mexico City has one of the highest incidences and mortality rates of acute lymphoblastic leukemia (ALL) in the world and a high frequency of early relapses (17%) and early mortality (15%). Otherwise, childhood overweight and obesity are reaching epidemic proportions. They have been associated with poor outcomes in children with ALL. The aim of present study is to identify if overweight and obesity are prognostic factors associated with survival rates in Mexican children with ALL. Methods: Multicenter cohort study. ALL children younger than 15 years old are included and followed-up. Overweight and obesity are classified according World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) criteria. Deaths and relapses are the main outcomes.
NCT04271215 — Leukemia, Lymphoblastic
Status: Active, not recruiting
http://inclinicaltrials.com/leukemia-lymphoblastic/NCT04271215/
The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.
NCT04228393 — Acute Lymphoblastic Leukemia, Pediatric
Status: Not yet recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-pediatric/NCT04228393/
Chinese Children Cancer Group Relapsed Acute Lymphoblastic Leukemia 2017 Study
Relapsed acute lymphoblastic leukaemia (ALL) has a poorer outcome than newly diagnosed ALL patients with only about 40% overall survival after re-treatment. The study CCCG Relapsed ALL 2017 study will adopt the UK R3 study stratification and treatment backbone with two new agents added. There will be a 4-week induction, followed by two consolidation courses. High-risk patients will receive allogeneic stem cell transplant. While intermediate and standard risk groups will continue maintenance treatment for another 2 years or one year. New agents will be added aiming at improving survival outcome. 1. Study of adding anti-CD20 antibody (rituximab) with chemotherapy: CD20 is found to be expressed in 40-50% of B-lineage ALL, and rituximab has been studied in adult ALL with superior survival (75% vs 47%,). There is little experience of using rituximab in pediatric ALL thus a CCCG Relapsed ALL 2017 Study will perform the study assessing the remission rate and MRD response of CD20+ ALL treated with rituximab. Six doses of rituximab and will be monitored the week 5 MRD and relapse rate as study outcome. (This arm was terminated in October 2020 after interim analysis showing lack of efficacy) 2. Adding bortezomid during the induction: The very early or early bone marrow relapse has low remission rate. Previous case studies showed that Bortezomib, a proteasome inhibitor, may achieve remission in refractory ALL, 80% remission in B-ALL with combination of chemotherapy and bortezomib. Thus adding bortezomib, may improve the remission rate, thus bridging to allogeneic stem cell transplant. Adding bortezomib in the relapsed chemotherapy protocol may increase the toxicity and even treatment related mortality. In this protocol, we suggested to add during the induction therapy.
NCT04224571 — Acute Lymphoblastic Leukemia, in Relapse
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-in-relapse/NCT04224571/
The Anxiety and Resisting Behavior Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia: Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of therapeutic video game.
NCT04199637 — Childhood Lymphoblastic Lymphoma
Status: Completed
http://inclinicaltrials.com/childhood-lymphoblastic-lymphoma/NCT04199637/
Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
NCT04196205 — Acute Lymphoblastic Leukemia ,Lymphomas
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-lymphomas/NCT04196205/
Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Brief Overview: Children and adolescents diagnosed with cancer will experience problems with learning, memory and attention during and after completing their cancer therapy. There are many factors that contribute to this problem, but investigators have recently identified that chemotherapy agents used in treating Acute Lymphoblastic Leukemia (ALL) may disrupt normal brain development. A novel device has been developed that may help correct this disruption. Direct Current Stimulation (DCS) uses a very low level of constant electrical current to stimulate specific parts of the brain. It has been used in patients with stroke to great benefit. Our study at St. Jude Children's Research Hospital is designed to see if this technique will benefit survivors of childhood cancer. Specifically, investigators wish to see if stimulating one part of the brain gives a greater benefit than stimulating another part of the brain. Primary Objective Evaluate the feasibility of conducting repeated on-site Transcranial Direct Current Stimulation (tDCS) in children who are long-term survivors of Secondary Objectives - To estimate the potential efficacy for powering a future larger study using tDCS to improve cognitive performance in children by suppressing over connected neural hubs in long-term survivors of childhood ALL. - To compare the performance of anodal stimulation of the frontal lobe to cathodal suppression of the superior temporal lobe on cognitive performance.
NCT04105530 — Acute Lymphoblastic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT04105530/