Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Childhood Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Lipid Regulating Agents

All Drugs and Chemicals

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

6-Months Atorvastatin Therapy; 40mg oral, once daily

6-Months Placebo (sugar pill); oral, once daily

6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.

6-Months of placebo (sugar) pill; oral, once daily

Sugar Pill (Placebo)

Aaron S Kelly, Ph.D.

Adult survivors of childhood cancer are at high risk of developing cardiovascular disease. Therapies used to treat many cancers, such as chemotherapy and radiation, likely cause damage to the surface of the artery wall called the endothelial layer, leading to the induction of atherosclerosis and eventual cardiovascular disease. HMG coenzyme A reductase inhibitors, or statins, improve endothelial function independent of cholesterol-lowering. In addition, statins have been shown to reduce arterial stiffness and slow arterial thickening. Despite strong evidence supporting the vascular benefits of statins in many different patient populations, these medications have never been studied in cancer survivors. Therefore, the overall objective of this study is to evaluate the effects of statin therapy on vascular health in young adult survivors of childhood cancer.

Twenty-four young adult (age 18-39 years old) survivors of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) will be enrolled in a six-month randomized, double-blind (participants and investigators), placebo-controlled pilot clinical trial comparing the effects of atorvastatin versus placebo on endothelial function and other measures of vascular health.

Our primary objective is to evaluate the effects of 6-months of statin therapy on conduit artery endothelial function in young adult survivors of childhood cancer. The investigators hypothesize that, compared to placebo, atorvastatin will significantly increase brachial artery flow-mediated dilation in survivors of childhood acute lymphoblastic leukemia and non-Hodgkin's lymphoma.

Adult survivors of childhood cancer are at seven times the risk of dying from cardiovascular disease compared to the general population. The increased risk is thought to be the result of the therapies used to treat the cancer such as chemotherapy and radiation. These therapies likely cause damage to the endothelial cells, which line the arterial wall and, when function properly, offer protection from atherosclerosis. Young adult survivors of childhood ALL have reduced endothelial function, or endothelial dysfunction, compared to healthy controls. Endothelial dysfunction is considered an early manifestation of atherosclerosis and therefore is an ideal target of therapy in order to reduce the risk of cardiovascular disease. Interventions that improve endothelial function in young adult survivors of childhood cancer may be beneficial in terms of mitigating the medium- and long-term risk of developing this chronic disease.

HMG coenzyme A reductase inhibitors, or statins, are widely used for cardiovascular disease risk reduction. These medications are primarily used to reduce levels of total- and low-density lipoprotein (LDL) -cholesterol. Meta-analyses have consistently demonstrated that statin therapy improves endothelial function in a wide array of patient populations. Beyond their well-described vascular benefits, statins are an attractive therapeutic option for cardiovascular disease risk reduction due to their strong safety profile.

Despite the clear potential for endothelial function improvement and cardiovascular risk reduction, statin therapy has never been evaluated in survivors of childhood cancer. Although statins have been well-studied in other patient populations at risk for cardiovascular disease, there is strong justification for evaluation in cancer survivors since the mechanisms responsible for the vascular problems in these individuals (treatment-induced vascular toxicity) differ from traditional atherosclerosis. Therefore, the objective of the current study is to assess the ability of statin therapy to improve endothelial function, arterial stiffness, and arterial thickening in young adult survivors of childhood cancer. The focus of the study will be on survivors of hematologic malignancies, acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma (NHL), since the former has been shown to be associated with endothelial impairments and both cancers share common treatment exposures (chemotherapy and radiation), which is likely the primary factor responsible for endothelial dysfunction in these individuals.

Twenty-four young adult (age 18-39 years old) survivors of childhood acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma (NHL)will be enrolled in a six-month randomized, double-blind (participants and investigators), placebo-controlled pilot clinical trial comparing the effects of atorvastatin versus placebo on endothelial function and other measures of vascular health. Following baseline testing, subjects will be randomly assigned (1:1) to either atorvastatin or placebo. Participants will return at 1-month and 3-months for assessment of safety (blood draw and adverse event assessment) and medication compliance and at 6-months for assessment of safety, medication compliance, and reassessment of baseline variables.

Statin Therapy in Young Adult Survivors of Childhood Cancer

Pilot Study of Statin Therapy in Young Adult Survivors of Childhood Cancer

At this time we have no plan to share the IPD.

Carotid Artery Compliance is a measure of arterial stiffness. Higher arterial stiffness places persons at higher risk for CVD.

University of Minnesota

6-Months Atorvastatin Therapy; 40mg oral, once daily

Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.

6-Months Placebo (sugar pill); oral, once daily

Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily

Total

Age, Categorical

Age, Continuous

Gender

United States

Region of Enrollment

Cameron Naughton

Physician withdrawals, loss to follow-up, drug compliance \<70%, unrelated injury, and self-withdrawal reduced number analyzed. Also, participant movement during FMD assessment and/or poor ultrasound image quality due to difficult brachial artery anatomy or poor circulation led to some unusable data and thus lowered the analyzable sample size.

Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months

Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.

Change From Baseline in Carotid Artery Compliance at 6-Months

Change From Baseline in Carotid Artery Distensibility at 6-Months

Change From Baseline in Pulse Wave Velocity at 6-Months

Change From Baseline in Augmentation Index at 6-Months

Change From Baseline in Carotid Intima-Media Thickness at 6-Months

Overall Study

In the treatment group, the child will receive the VR-based curriculum in addition to receiving the devices to use for 8 weeks.

In the control group, the child will still receive the devices to use for 8 weeks, but will not have the VR-based curriculum.

Rather than rely on mere exposure to devices, participants in the treatment group will receive a curriculum that integrates the devices into traditional content delivered through the after school program.

Virtual reality curriculum

Children will be able to use the same devices but will not have access to a curriculum that integrates the devices with traditional content delivered through the after school program.

No Virtual reality curriculum

Sun Joo Ahn, PhD

Kyle Johnsen, PhD

Lemuel LaRoche

This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings.

This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings. It will also empower youth to engage with the afterschool program at their own pace by providing a safe space to learn and practice their socioemotional skills. Implemented at scale, these benefits of a VR-integrated afterschool program will be able to address the issues of health inequity head on by expanding access to high quality afterschool content without incurring high operating costs. The results from this pilot study will provide a critical foundation to apply for an extramurally funded clinical trial to demonstrate the efficacy of a VR-integrated afterschool program on youth mental wellbeing.

Aim 1: Determine feasibility of a VR-integrated afterschool program where youth can access the VR content on their own at home.

Aim 2: Test the hypothesis that complementing the in-person afterschool program with VR will increase a) engagement and b) socioemotional competencies in youth.

Aim 3: Test the hypothesis that youth will demonstrate better mental wellbeing when the in-person afterschool program is complemented with VR.

Participants will be masked to which study condition they are assigned to.

Positive Youth Development in the Metaverse

Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth

De-identified data used in published analyses will be made available upon request to other researchers with a verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications. Intellectual property rights to all software applications and hardware products will be maintained by the University of Georgia.

Early Adolescent Temperament Questionnaire-Revised ( 1-Almost always untrue, 2-Usually untrue, 3-Sometimes true, sometimes untrue, 4-Usually true, 5-Almost always true)

Strengths and Difficulties Questionnaire (Not true = 0, Somewhat true = 1, Certainly true = 2)

Number of hours of programming delivered for both in-person and VR

University of Georgia

Associate Professor

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Constipation

Pelvic Floor Disorders

Signs and Symptoms, Digestive

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

PTNS

Sham PTNS

Shucheng ZHANG

ZhengTong YU

Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of children's constipation is full of challenges, and treatment methods are diverse.

Studies have shown that pelvic floor dysfunction is a common cause of intractable constipation in children. Zhang et al. have confirmed the role of pelvic floor dysfunction in pediatric constipation. At present, the main methods for pelvic floor dysfunction include surface electromyography and anorectal manometry which have been widely used in children with constipation and they are helpful for the diagnosis of pelvic floor dysfunction in children with constipation.

Sacral nerve electrical stimulation combined with pelvic floor rehabilitation is an effective method for the treatment of pelvic floor dysfunction. It offers a novel approach for the treatment of intractable constipation with pelvic floor dysfunction . At present, there are many methods for sacral nerve regulation. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as sacral nerve regulation, and has the advantages of small trauma, safety, and convenience. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. Therefore, in this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.

Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of childhood constipation is full of challenges, and treatment methods are diverse. For example, diet control, behavioral intervention and oral Laxative, bowl management, surgical treatment and other methods can be used for the treatment of childhood constipation. Therefore, a number of guidelines for constipation in children have been developed to regulate the treatment of constipation in children. Fiber intake and polyethylene glycol are recommended as the first line choice for constipation in North American and European guidelines. However, through clinical tests, the effectiveness of PEG3350 laxative and fiber does not last, or it does not work after long-term use. Therefore, additional treatment interventions are necessary. Zhang et al. applied traditional Chinese medicine to treat childhood constipation, which greatly improved the efficacy and reduced the recurrence rate, but there were still nearly 30% intractable constipation left, and other treatment methods were needed.

Studies have shown that secondary pelvic floor dysfunction is a common cause of intractable constipation in children. The incidence of pelvic floor dysfunction is high in children with constipation, and it has a great impact on the symptoms of constipation. Zhang et al. applied defecography to examine 76 children with constipation and found that there existed different pelvic floor dysfunction such as rectocele, puborectal muscle spasm, pelvic floor spasm syndrome and sigmoid hernia in the defecation of children with constipation. In addition, the pelvic floor dysfunction in children was mainly spastic, while in adults it was mainly flaccid. Although these results confirm the role of pelvic floor dysfunction in pediatric constipation, the pelvic floor function was not evaluated. At present, the main methods for pelvic floor function include surface electromyography and anorectal manometry.

Based on the above theory, Claire Zar-Kessler et al. completed a retrospective study of 69 children in which researchers compared the clinical outcome of patients who underwent pelvic floor physical therapy (n = 49) to control patients (n = 20) whom received only medical treatment (laxatives/stool softeners), determined by anorectal manometry and balloon expulsion testing and come to the conclusion that the new field of pelvic floor physical therapy is a safe and effective intervention for children with dyssynergic defecation causing or contributing to chronic constipation. In recent years, more and more studies have confirmed that childhood constipation is resulted from pelvic floor function.Also, it has been demonstrated that, after physical therapy, pelvic floor muscle was strengthened and it became fully continent of bowel in home and community settings. Therefore, constipation is one of the manifestations of pelvic floor dysfunction in children, surface electromyography assessment and anorectal manometry are helpful for the diagnosis of pelvic floor dysfunction in children.

Sacral nerve electrical stimulation combined with pelvic floor rehabilitation(PFR) is an effective method for the treatment of pelvic floor dysfunction. At present, there are many methods for sacral neuromodulation(SNM). Percutaneous sacral nerve stimulation is a effective method for sacral neuromodulation discovered in recent years. Studies have shown the efficacy of simultaneous SNM and PFR for the treatment of childhood constipation. This method is not only better than pelvic floor training and conventional treatment, but also safe and non-invasive. At present, there are many methods for SNM. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as SNM, and has the advantages of small trauma, safety, and convenience. PTNS has become a very effective method for SNM in recent years. Carlo Vecchioli Scaldazza et al. demonstrates the effectiveness of PTNS in women with over active bladder, improving their pelvic floor function. The result suggests that percutaneous artificial stimulation combined with PFR can be used for the treatment of constipation, especially in those with secondary pelvic floor dysfunction.

Therefore, for the treatment of intractable constipation in children, it is also necessary to determine whether there is pelvic floor dysfunction involved. In the children with pelvic floor dysfunction, relieving the pelvic floor dysfunction is an important treatment principle for the treatment of constipation. PTNS in combination with PFR offers a novel approach for the treatment of pelvic floor dysfunction and intractable constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. In this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.

Treatment group: PTNS and PFR treatment; Control group: ( Sham stimulation and PFR training)

PTNS and PFR in the Treatment of Childhood Constipation

Percutaneous Tibial Nerve Stimulation and Pelvic Floor Rehabilitation in the Treatment of Childhood Constipation

Rate of defecation without drugs or other auxiliary methods

Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).

Rate of bowel movements per week;Incidence of constipation.

The feelings of children during defecation;Rate of painful or hard bowel movements.

Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.

Rate of children who intentionally control or reduce the frequency of defecation.

Shengjing Hospital

Professor

Acute Graft Versus Host Disease

Ndella Ms DIOUF, MD

BRENDA Ms MALLON, MSc

LINE COUITCHERE, DOCTOR

Dr Aïssata BARRY, DR

NDELLA DIOUF, DOCTOR

The LALGFA2019 Recommendations redefine the standard risk criteria and propose to introduce anthracycline induction in so-called high-risk forms (LAL line T and LAL line B with leukocytosis greater than or equal to 50 G/L or in children less than 1 year of age or more than 10 years of age) as well as Endoxan and Methotrexate in high dose consolidation.

A few studies conducted in developing countries confirm that it is possible to significantly improve the prognosis of children with Acute Lymphoblastic Leukemia (ALL) provided that the centres can benefit from a precise and adapted protocol and logistical support.

The GFAOP has been working with units for the past 20 years and this is the second study put in place by the group for the treatment of LAL. The initial study was a feasibility study with the treatment of standard risk LAL. This study GFALAL2019 aims to include both standard and high-risk forms of LAL.

With this study it is hoped to:

1. Ensure the feasibility of these recommendations.
2. To show that the correct application of the therapeutic recommendations will result in a complete remission rate (CR) close to 85% at the end of the induction treatment.
3. The survival without relapse of patients in RC will be close to 65% at 5 years.

Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP

Availability of drugs. This is part of the project as we are working with Low or low to Middle Income countries.

Availability of drugs and adherence to protocol: Some centers may at times have to find locally the chemiotherapy for application of the protocol. The capacity of the units to do this is alos being studied. By looking at why treatment was not given. Was it because of lack of discipline regarding the attendance at the units for treatment, transport, accommodation, or medication not available ?

Evaluation of the CR j34 or J42 depending on the risk level High or standard.

The number of children who stop treatment without the consent of the doctor.

The vital status at the end of the first line of treatment.

the number of children in complete remission without relapse at the end of treatment .

Gustave Roussy, Cancer Campus, Grand Paris

French Africa Pediatric Oncology Group

Diseases and Abnormalities at or Before Birth

Digestive System Diseases

Congenital Abnormalities

Fecal Incontinence

Anorectal Malformations

Rectal Diseases

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Abnormalities

Imperforate Anus

The posterior sagittal approach to anorectal malformation (ARM) has radically changed the outcome of these patients, improving the preservation of anal sphincters, owing to their anatomical identification. However, in long term follow-up, fecal incontinence and severe constipation remain the most frequent and disabling postoperative clinical problems, having a significant influence on quality of life. Current therapeutic measures for Fecal Incontinence include biofeedback, sacral nerve stimulation, radiofrequency energy delivery, surgical treatment and sphincter replacement. Biofeedback combined with SNS has achieved satisfactory results. However, not all patients have an improvement in their weakened anal sphincter and achieve acceptable continence.

A detailed assessment of anorectal sphincter morphology and function can predict therapeutic outcome. Magnetic resonance imaging(MRI) can help to judge the anal atresia type, to display the presence and running of the fistula, and to show the nature of anal sphincter, such as the shape, thickness, directions and position of the anal sphincter complex and location in the pelvic floor and other systems malformations, finally to provide a reliable diagnostic basis for surgical program and prognostic assessment. High-resolution anorectal manometry (HR-ARM) is the latest internationally recognized examination for the evaluation of anorectal function. A standardised protocol of HR-ARM can characterise FI from dyssynergic or other neuromuscular and sensory problems. As a result, HR-ARM provides a more appropriate management in patients with FI. In order to assess whether patients with fecal incontinence should choose biofeedback therapy, our study included children with FI after anorectal malformation, and combined HR-ARM and MR to predict the efficacy of sacral nerve stimulation and pelvic floor rehabilitation.

The posterior sagittal approach to anorectal malformation (ARM) has radically changed the outcome of these patients, improving the preservation of anal sphincters, owing to their anatomical identification. However, in long term follow-up, fecal incontinence and severe constipation remain the most frequent and disabling postoperative clinical problems, with an important impact on quality of life. A cluster of physical and psychological problems appear in pediatric patients, including repeated infections, skin ulcer and scar, social anxiety disorder, behavioral problems, self-abasement or isolation and other problems, which cause children full of guilt and embarrassment and increase the risk of bullying.

Current therapeutic measures for FI include biofeedback, sacral nerve stimulation, radiofrequency energy delivery , surgical treatment, and sphincter replacement. Zhengwei Yuan et al. conducted a follow-up study on 31 patients with FI after ARM, and confirmed that biofeedback combined with SNS has a good effect on patients with FI after ARM. However,not all patients improve their impaired anal sphincter and acquire satisfactory continence. A lot of time and treatment costs are wasted. Therefore, it is necessary to clarify the indications for the application of biofeedback combined with SNS.

Severity of ARM affects the degree of development of internal and external anal sphincters. A detailed assessment of anorectal sphincter morphology and function can predict therapeutic outcome. In clinical practice, endoanal ultrasound and endoanal magnetic resonance imaging (MRI) are the main imaging modalities for the anatomical assessment of the anal sphincter complex. Sphincter MR is more suitable for observing the nature of the anal sphincter such as the shape, thickness, directions, and position of the anal sphincter complex and its location on the pelvic floor. MR examination has a high clinical value in the diagnosis of ARM. It can help determine the anal atresia type, display the presence and running of the fistula, evaluate the perianal muscle development and other systems' malformations, and finally provide a reliable diagnostic basis for surgical program and prognostic assessment. The role of MR is similar to that of EUS in some aspects. However, the sphincter MRI can clearly demonstrate the sphincter pattern, the position of the sphincter on the pelvic floor, and several indicators that cannot be detected by EUS. High-resolution anorectal manometry (HR-ARM) is the latest internationally recognized examination for the evaluation of anorectal function. A standardised protocol of HR-ARM can characterise FI from dyssynergic or other neuromuscular and sensory problems.Therefore, HR-ARM provides a more appropriate management in patients with FI. The anorectal manometry is a functional study that can evaluate the potential for muscular sphincterial recovery after BFB; the assessment derives greater benefit also from a morphological evaluation (MRI) in particular when the manometry is unfavorable.

The study included children with FI after ARM, and the investigators combined HR-ARM and MR to predict the efficacy of sacral nerve stimulation and pelvic floor rehabilitation to determine whether patients with fecal incontinence should choose biofeedback therapy.

Management of FI After Surgery of ARM

Strategies for Predicting the Efficacy of Sacral Nerve Stimulation With Pelvic Floor Rehabilitation in the Management of Fecal Incontinence After Surgery of Anorectal Malformation.

Average maximum pressure (mm Hg) over the functional anal canal length during the 30-s period of rest

Maximum pressure (mm Hg) sustained over the duration of the 5-s squeeze maneuver

Length of anal canal (cm) in which pressure exceeded rectal pressure by \>5 mm Hg

Three measurements were made laterally for the external anal sphincter where the muscle appeared thickest during sphincter MRI , and an average value was determined.

The thickness of the internal anal sphincter was measured three times at a centimeter above the external sphincter during sphincter MRI.

Whether the rectum crosses the center of the puborectalis muscle on sphincter MRI.

select the pena questionnaire to assess bowel function in patients with fecal incontinence after anorectal malformation after treatment.

select the pena questionnaire to assess bowel function in patients with fecal incontinence after anorectal malformation before treatment.

Oral placebo was added to conventional chemotherapy

Oral RIF was added to conventional chemotherapy

Realgar Indigo naturalis formula was used in the induction, consolidation and intensive treatment of patients in intermediate or high risk

Realgar Indigo naturalis formula

Conventional chemotherapy

Pei J Fang, Doctoral

Jian Wang, Master's

Xin Y Chen, Doctoral

In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the 5-year OS of patients with first recurrence is still less than 50%. A number of in vitro studies have shown that arsenic trioxide (ATO) can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can produce similar pharmacological effects to ATO. Based on the R3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL children, in order to improve the MRD negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed ALL.

In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the 5-year OS of patients with first recurrence is still less than 50%, and the prognosis of children with intermediate and high risk is even worse, so there is an urgent need to explore new and effective treatment methods. A number of in vitro studies have shown that arsenic trioxide (ATO), which is safe and effective in the treatment of APL, can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can produce similar pharmacological effects to ATO. The UK ALL R3 protocol is an advanced and mature clinical trial. The results showed that the MRD negative rate after induction chemotherapy and the 2-year DFS of traditional chemotherapy ±HSCT in children with intermediate and high risk did not reach 50%. Based on the R3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL children, in order to improve the MRD negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed ALL.

South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol

Complete response rate after induction treatment in two groups

First Affiliated Hospital, Sun Yat-Sen University

Third Affiliated Hospital, Sun Yat-Sen University

Zhujiang Hospital

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou First People's Hospital

Huizhou Municipal Central Hospital

First Affiliated Hospital of Shantou University Medical College

Zhongshan People's Hospital, Guangdong, China

Zhongshan Bo Ai Hospital

First Affiliated Hospital of Guangxi Medical University

LiuZhou People's Hospital

Second Xiangya Hospital of Central South University

Hainan People's Hospital

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Participants will participate in computer-based cognitive training at the end of therapy.

At the end of therapy, participants will participate in the current standard-of-care which does not include computer-based cognitive training.

Cogmed is a computer-based cognitive training program that consists of rotating exercises that train attention and working memory. The exercises are presented in a child-friendly, game-like format. The program is completed at home for 15-45 minutes each weekday for 5-9 weeks.

Cognitive training

Lisa M. Jacola, PhD

Computer-based cognitive training has been found to be helpful for improving attention and working memory in pediatric and adult patients with existing cognitive difficulties. A previous study was conducted at St. Jude Children's Research Hospital with survivors of childhood cancer who were experiencing difficulties with attention and/or working memory. Findings from that study indicated that the use of Cogmed, computer-based cognitive training, is effective in improving attention and working memory in survivors.

Researchers want to learn whether Cogmed intervention completed at the end of therapy for acute lymphoblastic leukemia will be effective for all survivors (i.e., regardless of whether they have existing difficulties).

PRIMARY OBJECTIVES:

* To evaluate the overall participation rate in a randomized, standard-of-care controlled trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
* To estimate the study completion rate in a randomized, standard-of-care controlled trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
* To estimate the compliance rate for participants randomized to the intervention arm of a computerized cognitive intervention administered at the end of TOTXVI therapy.
* To estimate the standard deviation for the overall cohort on a measure of working memory.
* To use neuroimaging data collected in the context of the Total Therapy XVI trial to explore candidate biomarkers predictive of response to the computerized cognitive intervention.

Participants enrolled on the TOTXVI protocol at SJCRH will be randomized to either complete the Cogmed intervention at the end of their therapy, or to a standard-of-care condition.

Cogmed is a computer-based cognitive training program that consists of rotating exercises that train attention and working memory. The exercises are presented in a child-friendly, game-like format. Training is completed at home in 25 sessions for 15-45 minutes each weekday for 5-9 weeks. A research team member serves as a coach who monitors progress and provides support through weekly phone calls with study participants and their parents/guardians. Information regarding compliance and performance is tracked over the internet and used to tailor feedback during weekly telephone coaching.

Neurocognitive assessments will be conducted at baseline, immediate-post (3-4 months after baseline), and 8 month follow-up (12 months after baseline).

Participants will be randomized to either the intervention group to receive cognitive training or to the standard of care group who will not receive cognitive training.

The study examiner (clinical research assistants or psychological examiners) will not know which group of participants is associated with each arm.

Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI

Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI: A Pilot Study

The magnitude and standard deviation of pre- to post-change in Spatial Span Backward will be estimated for each group and for the overall group.

St. Jude Children's Research Hospital

Neoplasm, Residual

Retrospective chart review of children and young adults with ALL/LBL enrolled on treatment protocols in the POB

Nirali N Shah, M.D.

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.

...

Minimal residual disease detection in the bone marrow is highly prognostic for disease relapse in patients with acute lymphoblastic leukemia (ALL) and is determined based on a single bone marrow aspirate sample. Our anecdotal experience over the past decade in the Pediatric Oncology Branch (POB) has led us to believe that a bone marrow aspirate as the only metric for disease detection may not be adequate, but a systematic review detailing our experience and reporting on instances where we have identified discrepancies in disease status has not been performed to confirm our hypothesis. Additionally, patients with ALL also may have CNS involvement by disease. Current standard of care assessment of disease in the central nervous system (CNS) consists of cerebrospinal (CSF) fluid sampling and evaluation for blasts by cytology only, which may not identify occult levels of CNS disease.

Flow cytometry-based CSF testing is highly dependent on the media used for CNS specimens and the expertise of the center performing these studies. NCI Flow cytometry has established expertise in CNS disease evaluation. In evaluation of patients with ALL for POB treatment protocols, we have observed cases where there is a discrepancy between cytopathology and flow cytometry results. Recent literature in ALL indicates that subclinical CNS disease may be relevant to patient outcomes. With a primary goal of identifying the optimal methods for disease detection in ALL, this protocol is a retrospective chart review of bone marrow evaluations and cerebrospinal fluid results in patients with ALL or lymphoblastic lymphoma (LBL) who underwent treatment or evaluation in the Pediatric Oncology Branch of the National Cancer Institute. This study will not involve the use of specimens or participant contact. All data that is needed has already been collected and is available in CRIS records. Data will only be collected on patients with ALL or LBL where routine PET scans to follow EM disease, bone marrow and/or CSF evaluations were done as standard of care or on study and will largely be from trials where Dr. Nirali Shah is or has served as the PI (e.g., 12-C-0112, 15-C-0029.)

Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch

Retrospective Study of Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch

To identify the frequency and degree of disease discrepancies in identification of bone marrow involvement by ALL when comparing bone marrow biopsy to bone marrow aspirate to flow cytometric disease detection.

To identify the frequency of discrepancies in identification of CNS involvement by leukemia when comparing flow cytometry to cytopathology.

To identify and characterize immunophenotypic changes in leukemic cells over time and in response to targeted therapy.

To comprehensively characterize EM disease including incidence, presentation, risk factors for and radiographic presentation of disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Statin Therapy in Young Adult Survivors of Childhood Cancer	NCT01733953	Cardiovascular ... Childhood ALL Childhood NHL	Atorvastatin Sugar Pill (Pla...	18 Years - 39 Years	University of Minnesota
Positive Youth Development in the Metaverse	NCT05858593	Healthy Healthy Lifesty... Childhood ALL Behavior, Child	Virtual reality... No Virtual real...	9 Years -	University of Georgia
PTNS and PFR in the Treatment of Childhood Constipation	NCT05059756	Constipation Childhood ALL Pelvic Floor Di...	PTNS Sham PTNS	10 Years - 14 Years	Shengjing Hospital
Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP	NCT04794296	Childhood ALL		- 18 Years	French Africa Pediatric Oncology Group
Management of FI After Surgery of ARM	NCT05621629	Fecal Incontine... Childhood ALL Anorectal Malfo...		4 Years - 18 Years	Shengjing Hospital
South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol	NCT05682131	Arsenic Trioxid... Childhood ALL	Realgar Indigo ... Conventional ch...	1 Year - 14 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP	NCT04794296	Childhood ALL		- 18 Years	French Africa Pediatric Oncology Group
Management of FI After Surgery of ARM	NCT05621629	Fecal Incontine... Childhood ALL Anorectal Malfo...		4 Years - 18 Years	Shengjing Hospital
Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI	NCT03187977	Acute Lymphobla...	Cognitive train...	4 Years -	St. Jude Children's Research Hospital
Optimal Methods of Disease Detection in Children and Young Adults With Acute Lymphoblastic Leukemia in the Pediatric Oncology Branch	NCT03627208	Leukemia, Lymph... ALL, Childhood		2 Years - 40 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for childhood all