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This is a leg brace that is made to fit the contour of the patient's foot, ankle, and lower leg. The two pull solid ankle AFO is fabricated from a rigid polypropylene outer boot and a more flexible silicone inner boot. It is commonly used in rehabilitation to improve gait in pediatric and adult populations. A certified orthotist fabricates the device. This device is lawfully marketed in the United States. It is not regulated by the FDA.

An ankle resting night spring (RNS) is an off-the-shelf device that provides static sagittal plane dorsiflexion. The RNS is worn nocturnally to provide maximal stretch/length to the gastrocsoleus to maintain or increase dorsiflexion ROM and/or to prevent further regressions in ankle range. It is not regulated by the FDA.

Solid ankle foot orthotic

Resting night splint

Lynn Tanner, MPT

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.

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. Children undergoing treatment for cancer can suffer from decreased flexibility, strength, balance and endurance from the cancer and from direct effects of the chemotherapy agents. These impairments have been shown to continue years after treatment end, with adult survivors of cancer being less physically active than their siblings. Children, whose chemotherapy includes vincristine, can develop damage to their peripheral nervous system affecting the strength, sensation, and flexibility in their hands and feet. This can then lead to a change in their walking pattern and ankle flexibility and likely contributes to decreased physical activity level and fatigue.

In our clinical practice and pilot work, we know that solid ankle orthotics can be effective in improving gait quality and ankle flexibility. However, in other areas of the country, researchers have published on the effectiveness of using a different type of brace, called a resting night splint, to improve gait and ankle function. Thus, we are studying the comparative efficacy of these two approaches.

Our published pilot study demonstrated that children with cancer were able to wear solid ankle orthotics without an impact on their safety. This study will further the research by comparing the effect of the solid ankle foot orthotic against a resting splint worn at night on walking and ankle flexibility in children with cancer.

Ankle foot orthotics improve a walking pattern by positioning the foot and ankle so that the toe can clear the floor more easily and the child can take a longer step. This decreases the energy needed for a child to walk, allowing the ability to walk longer distances or increase physical activity level. The AFO will also increase ankle flexibility by stretching the muscle while walking. If the child or adolescent walks with an increased step length, they will give a greater stretch to the calf muscles while walking. In contrast, the resting night splint can increase ankle flexibility by providing a gentle stretch to the calf muscles while sleeping, therefore allowing improved ankle movement when walking and a longer step length. We will examine the impact of these orthotics on walking, ankle flexibility, ankle strength, aerobic capacity, self-reported fatigue, as well as the ability of the children to wear the orthotic as prescribed and the severity of the damage to the nervous system.

Children and adolescents who are found to have ankle weakness, ankle tightness, and damage to their peripheral nervous system as a result of cancer treatment will be referred to the study by the treating physical therapist (PT). The PT will contact the investigators and they will invite the child or adolescent to participate in the study. Using previously established measurements in children with cancer, we will measure walking pattern, ankle strength, ankle flexibility, foot posture, level of physical activity, and level of fatigue prior to the orthotic intervention. The subject will then be randomized between an 8-week AFO or RNS intervention. The orthotic will be made with a small temperature sensor that will collect data on wearing time of the brace. After 8 weeks of orthotic wear, we will repeat the measurements and compare results between the two orthotic types.

Each group gets one of the 2 types of orthotics.

Assessor blinded to the intervention type

Impact of an Orthotic Intervention in Children With Peripheral Neuropathy

Impact of an Orthotic Intervention on Physical Function in Children With Chemotherapy-induced Peripheral Neuropathy

Length of the step in participant's gait measured by the gaitrite analysis system

Passive and active ankle dorsiflexion measured by goniometry

Ankle dorsiflexion and plantarflexion strength measured by dynamometer

Measured by the 6-minute walk test distance

Pine Tree Apple Tennis Classic Foundation

St. Jude Children's Research Hospital

Children's Hospitals and Clinics of Minnesota

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

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Anti-Infective Agents

Antirheumatic Agents

Dexamethasone

Etoposide

Cytarabine

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Dexamethasone acetate

Etoposide phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Enzyme Inhibitors

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Patients will receive lymphodepleting chemotherapy, one hour prior to infusion of CAR T-cells patients will receive tocilizumab IV 8 mg/kg (max 800 mg) over 1 hour. Patients then receive CD19-CAR T cells IV on day 0.

anti-CD19 chimeric antigen receptor - transduced T-cell given IV

Chimeric Antigen Receptor T-Cell Therapy

Tocilizumab

The purpose of this study is to evaluate the safety and efficiency of autologous CD19 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage acute lymphoblastic leukemia

The main objectives of the study are:

1. To investigate the safety of auto-CD19 CAR T-cells therapy among children and young adults with refractory/relapsed B-cell ALL on the basis of prospective evaluation of adverse affects frequency and severity according to CTCAE v.4
2. To study the efficacy of auto-CD19 CAR T-cells therapy among children and young adults with refractory/relapsed B-cell ALL on the basis of proportion of patients in haematological and molecular remission at 28 days after infusion.
3. To evaluate long-term efficacy of auto-CD19 CAR T-cells therapy among children and young adults with refractory/relapsed B-cell ALL on the basis of overall and event-free survival at 1 and 3 years after infusion.

The novelty of this study will be cytokine release syndrome prophylaxis by tocilizumab Patients will receive fludarabine 120 mg/m2 (totally) intravenously (IV) over 30 minutes on days -5 to -2 and cyclophosphamide 750 mg/m2 IV over 60 minutes on day -2. One hour prior to infusion of CAR T-cells patients will receive tocilizumab IV 8 mg/kg (max 800 mg) over 1 hour. Patients then receive CD19-CAR T cells IV over 20-30 minutes on day 0.

This is a dose-escalation study of CD19-CAR T cells. Dose escalation consistently:

* Level 1 5х105/kg CD19 CAR-T lymphocytes
* Level 2 1х106/kg CD19 CAR-T lymphocytes
* Level 3 3х106/kg CD19 CAR-T lymphocytes
* Level 0 1х105/kg CD19 CAR-T lymphocytes (in case of dose-limiting toxicity at dose Level 1) In case of severe side affects next dose will be reduced to the previous lower dose.

Based on interim analysis the following dosing approach based on stratification by the initial leukemia burden will be implemented starting November 2019:

• Patients with low disease burden (\<15% blast cells in BM) will receive a lymphodepletion chemotherapy of fludarabine IV (total dose 120mg/m2) and cyclophosphamide IV (total dose 750mg/m2) over 5 days.

CD19 CAR-T cells will be infused IV in dose 1x106/kg on day 0.

• Patients will high disease burden (\>15% blast cells in BM) will receive a lymphodepletion chemotherapy of fludarabine IV (total dose 120 mg/m2), cyclophosphamide IV (total dose 750 mg/m2), cytarabine IV (total dose 900 mg/m2), etoposide IV (total dose 450 mg/m2), dexamethasone IV (total dose 30 mg/m2) over 5 days.

CD19 CAR-T cells 1st dose will be infused IV on day 0 - 0,1x106/kg, 2nd dose will be infused IV between day 7 and 14 - 0,9x106/kg.

CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL

A Single-Arm Phase I/II Study Evaluating the Safety and Clinical Efficacy Of the 2-nd Generation CD19 Autologous CAR T Cells on the CliniMACS Prodigy Automated Manufacturing Platform in Treatment of Paediatric And Young Adult Patients With Relapsed/Refractory B-lineage Acute Lymphoblastic Leukemia

incidence of grade 3-5 SAE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 occurring within 30 days of CD19CAR T-cell infusion

incidence of grade 3-4 Severe Cytokine Release Syndrome

incidence of grade 3-5 neurotoxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 occurring within 30 days of CD19 CAR T-cell infusion

Proportion of patients in MRD-negative remission among all enrolled patients

Proportion of patients in hematologic remission among all patients with morphological disease (NO CR) at enrollment

Persistence/frequency of CD19 CAR T lymphocytes in peripheral (FC+qPCR)

Duration of B-cell aplasia and hypogammaglobulinemia, time 0 - day of CD19-CAR T cells infusion

the probability of survival, time 0 - day of CD19-CAR T cells infusion

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of an Orthotic Intervention in Children With Peripheral Neuropathy	NCT03655587	Gait, Drop Foot Chemotherapy-in... Acute Lymphocyt... Rhabdomyosarcom... Wilms Tumor	Solid ankle foo... Resting night s...	5 Years - 14 Years	Children's Hospitals and Clinics of Minnesota
CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL	NCT03467256	B-cell Acute Ly... Acute Lymphocyt...	Chimeric Antige... Fludarabine Cyclophosphamid... Tocilizumab Cytarabine Etoposide Dexamethasone	3 Months - 25 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Spots Global Cancer Trial Database for acute lymphocytic leukemia, pediatric