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MT2019-35: NeurotoxicityProphylaxis with Intrathecal Dexamethasone and Simvastatin in Adults Receiving CAR-T Treatment
This study is designed to determine the feasibility of administration, safety and tolerability of IT dexamethasone and simvastatin therapy in patients receiving axi-cel therapy while providing preliminary estimates of efficacy.
Joseph Maakaron
All
18 Years to 80 Years old
Early Phase 1
STUDY00009175
STUDY00009175
Inclusion Criteria:
18- 80 years of age
One of the following histologies:
Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or
Primary mediastinal B-cell lymphoma, or
High grade B-cell lymphoma, or
DLBCL arising from follicular lymphoma
Disease status:
Chemotherapy refractory disease after ≥2 lines of chemotherapy, or
Relapsed with no remission after ≥1 lines of salvage chemotherapy, or
Relapsed following autologous hematopoeitic stem cell transplantation (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post auto HCT, the subject must have no complete response, or relapse after the last line of therapy
Performance Status
ECOG performance status 0-2
Adequate organ function defined as:
Renal function defined as:
eGFR ≥ 30 mL/min/1.73 m^2
Liver function defined as:
ALT and AST ≤ 5 times the ULN for age (unless due to disease)
Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA
Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment as outlined in axi-cel protocol.
Able to provide written voluntary consent (or LAR consent for adults with diminished capacity) prior to the performance of any research related tests or procedures
Availability of a certified practitioner to perform the lumbar punctures
Exclusion Criteria:
Allergies, or intolerance to simvastatin or dexamethasone
Already receiving a statin drug for hypercholesterolemia and unwilling to change medication to 40 mg/day of simvastatin
Active uncontrolled CNS lymphoma. Patients with history of CNS lymphoma who have been adequately treated are eligible
Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD).
Uncontrolled active hepatitis B or hepatitis C
Active HIV infection
Uncontrolled acute life threatening bacterial, viral or fungal infection
Unstable angina and/or myocardial infarction
Risk factors that preclude a safe lumbar puncture (high intracranial pressure, bleeding diathesis that cannot be reversed or corrected, need for uninterrupted anticoagulation, platelets < 50K that cannot be corrected with transfusional support
Pregnant or breastfeeding as agents used in this study are Pregnancy Category C (dexamethasone) and X (simvastatin). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of study registration. Simvastatin, Dexamethasone, Simvastatin, Dexamethasone
Lymphoma
Clinics and Surgery Center (CSC)
National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease (NPC-QIC)
Kavisha Shah
All
to 15 Months old
STUDY00004329
STUDY00004329
Inclusion Criteria:
Fetuses or newborns diagnosed with HLHS or other univentricular condition
Intended to undergo Norwood procedure
Exclusion Criteria:
None Collaborative Learning Network, Collaborative Learning Network
Hypoplastic Left Heart Syndrome (HLHS)
Autonomic regulation of blood pressure in premature and early menopausal women
The goal of this study is to learn more about the effects of menopause on women's blood pressure and heart health. We are looking for women between the ages of 35 and 70 years to participate in the study. Participants may be pre- or postmenopausal; we are specifically interested in evaluating the influence of premature (< age 40 years) and early (< age 46 years) menopause.
Manda Keller-Ross
Female
35 Years to 70 Years old
STUDY00004979
STUDY00004979
Inclusion Criteria:
Aged 35-49 or 50-70 years of age who experienced premature (<40) or early (≤45) menopause
Premenopausal 35-49 years of age
Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of >30 mIU/mL
Exclusion Criteria:
Current nicotine/tobacco use within the past six months
Are diabetic or asthmatic
Have diagnosed significant carotid stenosis
Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
Have existing metabolic or endocrine abnormities
Take any heart/blood pressure medications that are determined to interfere with study outcomes
IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
Are pregnant or breastfeeding Microneurography to measure muscle sympathetic nerve activity (MSNA), Baroreflex sensitivity testing, Sympathoexcitatory Maneuvers, Blood tests, Microneurography to measure muscle sympathetic nerve activity (MSNA), Baroreflex sensitivity testing, Sympathoexcitatory Maneuvers, Blood tests
Hypertension, Menopause, Premature, Menopause, Blood Pressure
Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
This is a validation study to evaluate the acceptability, feasibility and impact of CICADAS (Care Improving Cognition for ADolescents on the Autism Spectrum), a clinician-assisted, mobile application that aims to prime the brain to engage in flexible, adaptive long-term learning about social-emotional events through closed-loop technology. The goal of this study is to evaluate the CICADAS app in adolescents with Autism Spectrum Disorder (ASD).
Suma Jacob
All
11 Years to 18 Years old
N/A
STUDY00010997
STUDY00010997
Inclusion Criteria:
Potential participant is between the age of 11 and 18 (inclusive) at the time of consent.
Potential participant has a clinical diagnosis of Autism Spectrum Disorder (ASD), as confirmed by medical/clinical records or standardized assessments/interviews (e.g., Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) or Autism Diagnostic Interview - Revised (ADI-R)).
Potential participant has an IQ Score > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) or a comparable measure in medical/clinical records.
Potential participant has normal or corrected to normal vision (20/20 or better; self/parent-reported.
Potential participant has normal hearing (self/parent-reported).
Potential participant is a fluent English speaker, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician, to ensure reasonable neuropsychological results on key assessments.
Potential participant has adequate sensorimotor capacity to perform the intervention and study activities, including visual capacity adequate to read from a computer screen or mobile device at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician and/or study team.
Potential participant must be clinically stable as a result of therapy or medication regimen for 4 weeks prior to enrolling into the study.
Potential participant has reliable access to the internet.
Exclusion Criteria:
Potential participant has history of psychotic disorders and/or seizure disorder and/or seizure episodes within the last 2 years.
Potential participant has a motor/perceptual handicap that prevents digital device use, as determined by the screening clinician and/or study team.
Potential participant has problems in performing assessments or comprehending or following spoken instructions, as determined by the screening clinician and/or study team.
Potential participant has medical illnesses/genetic syndromes deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, ongoing chemotherapy or other cancer treatment.
Potential participant has a history of head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
Potential adult participant scores less than a 14 (75%) on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). Please note, this criteria applies only to adult participants, age 18, at the time of screening. CICADAS and then PEERS, PEERS + CICADAS and then no-contact, PEERS + Active Comparator and then no-contact, CICADAS and then PEERS, PEERS + CICADAS and then no-contact, PEERS + Active Comparator and then no-contact
Autism Spectrum Disorder
Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension A 5-year longitudinal observational study of patients with cirrhosis undergoing TIPS placement
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.
Nicholas Lim
All
18 Years to old
STUDY00014403
STUDY00014403
Inclusion Criteria:
Subjects over the age of 18 able to provide consent or have a legally authorized consent in the event the subject is unable to consent due to a transient clinical condition
Subject scheduled to undergo a TIPS procedure
Exclusion Criteria:
Minors under the age of 18 at the time of enrollment
Prisoners
Pregnant Women
Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care Cirrhosis, Liver, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Clinics and Surgery Center (CSC)