Both pediatric and adult patients can be eligible to participate
The pediatric cohort is defined as age younger than 18 years.
The first 6 patients must be >= 18 and =< 65 years old. The subsequent patients may include pediatric patients >= 12 and =< 65 years old. Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician.
Children are excluded from this study, but will be eligible for future pediatric trials
In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (i.e., >= 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen, or Ph+ disease
Presumed pediatric gliomas (grades I-IV) on MRI that are determined to be candidates for MLA by the treating neurosurgeon
Recurrent pediatric brain tumors determined candidates for MLA as determined by the treating neurosurgeon
Patients age 18 to 70 years old; eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician; patients age 2-17 years may be enrolled after at least 10 adults (ages 18-70 years old) have been assessed for safety at day 30
Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician; patients age 2-17 years old may be enrolled after at least 4 adults (ages 18-65 years old) have been treated without toxicity
Pediatric patients (age 7-18 years) will be entered only after 3 adult patients have been entered without dose limiting toxicity
Inclusion Criteria:\n\n Caregivers\n\n - Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric\n cancer survivors\n\n - 18 years or older\n\n - Fluent in English\n\n Pediatric Cancer Survivors\n\n - Diagnosis of cancer\n\n - between 5-17 years of age at study entry\n\n - off active cancer treatment for 6 months to 4 years, or in the maintenance phase of\n treatment\n\n - reside with a participating caregiver\n\n - able to engage in PA tailored to current medical status\n\n - NOT taking medications that affect body weight, e.g., steroids within 6 months of\n enrollment\n\n - at or above the 85th BMI %ile.\n\n Exclusion Criteria:\n\n Caregivers\n\n - are non-ambulatory\n\n - do not reside with the PCS at least 50% of the time.\n\n Pediatric cancer survivor\n\n - relapse during the intervention\n\n - taken a medication known to affect body weight such as oral steroids or antipsychotic\n medications within 6 months of enrollment
Age > 18 years. Because no dosing or adverse event data are currently available on the use of AR-67 in patients < 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
ENROLLMENT: Signed informed consent and if applicable pediatric assent.
DMG biopsy/resection is planned for the clinical care of the patient independent of study participation by the treating pediatric neurosurgeon and neuro-oncologist
Children are excluded from this study, but will be eligible for future pediatric trials
Pediatric patients with progressive DIPG
Serum total bilirubin < 2 mg/dl; patients with Gilbert’s syndrome are excluded from the requirement of a normal bilirubin and patients will not be excluded if liver enzyme elevation is due to tumor involvement; NOTE: adult values will be used for calculating hepatic toxicity and determining eligibility, as is standard on Pediatric Oncology Branch (POB) phase I trials
pediatric Phase 1 Part B: 2 to <16 years old
Standard pediatric indications for myeloablative transplantation for patients undergoing HSCT at Children’s National Medical Center per institutional guidelines
Pediatric patients (younger than 18 years) will be excluded.
Age greater than or equal to 1 year but less than or equal to 55 years (myeloablative regimen 4); eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician; patients > 55 but < 65 years who have a performance status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s)
Both pediatric and adult patients of any age are eligible
Because no dosing or adverse event data are currently available on the use of ENMD-2076 in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
Age initiated after limitation - 18 years or older. A separate pediatric study is proposed to evaluate tolerance to the drug in children.
PHASE 3A: AYA SURVIVOR ELIGIBILITY: At least 2 years from treatment for any pediatric cancer diagnosed at age 0-19
PHASE 3B: PATIENT ELIGIBILITY: At least 2 years from treatment for any pediatric cancer diagnosed at age 0-19
Caregiver (age 18 years or older) of a patient who will be hospitalized to undergo first-time autologous (self) or allogeneic (alternative donor) BMT in the University of Michigan Mott Children’s Hospital Pediatric BMT Unit
Patients who have been readmitted to Pediatric BMT unit after initial transplant (not already in the study)
Pediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite; patients may or may not be receiving intrathecal chemotherapy
Measured creatinine clearance more than 60 mL/min; the updated Schwartz formula should be used for pediatric patients (>= 5 to 12 years old)
Pediatric patients with ALL diagnosis, treated at the University of Minnesota Amplatz\n Children's Hospital or Children's Hospitals and Clinics of Minnesota
Pediatric patients, as pediatric cirrhosis is uncommon
All ambulatory patients taken care of by the participating pediatric hematology/oncology clinics will be eligible
PHASE I: MedStar Georgetown University Hospital (MGUH) pediatric primary care providers (pPCP) providers
PHASE II: Presenting at MGUH pediatric outpatient center in Washington DC for a well-visit exam
Measured creatinine clearance more than 60 mL/min; the updated Schwartz formula should be used for pediatric patients (>= 5 to 12 years old)
Patients with a known or suspected malignancy who are receiving care from a pediatric oncologist and are already scheduled to receive an outpatient PET/CT examination
Patient is being evaluated or receiving treatment by the pediatric oncology division at the University of Kentucky
PEDIATRIC PATIENTS:
Individual pediatric patient with current or previous known or suspected thyroid cancer or nodule(s)
Females age ? 18 years old
Age ?18 years old
Age ?12 years old
Age greater than or equal to 18 years old at the time of informed consent
Age ? 18 years old (? 20 years old in Japan);
Age greater than or equal to 16 years old
Performance status < 90% in patients 70 years old or greater, < 80% in patients less than age 70 years
Age <18-years-old.
Must be < 70 years old with no matched 5/6 or 6/6 sibling donor; patients >= 70 and =< 75 years of age may be eligible if they have a co-morbidity score =< 2
Age ? 18 years old.
Age: ?12 months to <18 years old at the time of informed consent
Age ? 18 years old
Age ? 18 years old.
DONOR: Age >= 18 to =< 77 years old
DONOR: Age >= 13 years old (yo) and =< 75 years
Age ? 18 years old
Age ? 18 years old
Age <18-years-old.
Age <18-years-old.
Age < 18-years-old.
At Children’s National Medical Center only: age > 4 years old and < 24
At University of Oklahoma: age > 17 years old and =< 55 years for recipient
Age >=18 years old
Age ? 18 years old.
Age <18-years-old.
Age ? 18 years old.
Age < 55 years old and > 4 months
DONOR: age >= 18 years old
Age 8-16 years old at the time of consent
Age >/=18 years old.
Patients above >= 65 years old should have an age-adjusted co-morbidity index of =< 3
DONOR: Age >= 18 to =< 75 years old
Age 40 years old to 74 years old
Age >= 18 years for the feasibility phase; age >= 10 years old AND >= 50 kg for the phase II portion
Age 18-75 years (patient is older than 18.0 and less than 76.0 years old)
Patients age ?18 years old
Male patients age ?18 years old
Male, age between 50-70 years old
Be age ? 18 years old.
Subject is between 18 years old and 75 years old, inclusive
Must be at least 5 years old and enrolling on SJMB12
At least 5 years old at time of consent to remediation intervention
>= 11 and < 25 years old at enrollment
Adult (? 18 years old)
Treatment-naive participants with AML who are >/=75 years old
Patients ? 18 years old
Man or woman >= 18 years old.
Patients must be at least 18 years old.
DONOR: < 6 months old and > 75 years old
Subjects 1 and 2 (in cohort 1) will be >= 12 years’ old
Patients 18 to 70 years old
The patient is ?18 years old.
The patient is at least 18 years old.
Patients 0-49 years old will be enrolled in Arm A or C (high-intensity)
Patient must be at least 18 years old at the time of consent.
Patients must be at least 18 years old.
Is aged ?20 years old in Japan or ?18 years old in other countries
Initially only patients who are >= 16 years old will receive HA-1 TCR T cell infusions on the protocol; younger patients may be screened, enrolled in the protocol and monitored for relapse but will not be eligible for infusion until at least one patient >= 16 years old has been treated and discussed with the Food and Drug Administration (FDA)
At least 18 years old at the time of informed consent
Age greater than or equal to 16 years old; if patients 16-17 years old are enrolled in the trial, they will only be enrolled after 3 patients >= 18 years old have been treated, and the treatment has been shown to be safe
Patients ?18 years and ?80 years old (The 3 first patients at Dose Level 1 will be < 65 years old. Enrollment of patients ? 65 years old must be approved by the DSMB after the completion of cohort 1).
Patient is ? 18 years old at the time of informed consent.
Patients enrolled onto the dose-finding phase of the study must have an identified donor and transplant strategy prior to initiation of the lymphodepletion regimen. Patients enrolled in the Expansion Phase of the Study: Relapsed/Refractory Cohort • Patients ?18 years old with relapsed or primary refractory acute myeloid leukemia. Patients Enrolled in the Dose-Escalation Phase of the Study •Patients ?18 years and ?75 years old (The 3 first patients at Dose Level 1 will be <65 years old. Enrollment of patients ? 65 years old must be approved by the DSMB after the completion of cohort 1) Newly Diagnosed Cohort • Patients with newly diagnosed, untreated Acute Myeloid Leukemia (as defined by World Health Organization (WHO) criteria,) who meet criteria for the European Leukemia Net (ELN) Adverse genetics prognostic group. Eligibility criteria for UCART123 administration
Creatinine =< 1.5 mg/dL for patients 12 years old and older and =< 1 for patients younger than 12 years old.
Female ? 18 years old.
IMMUNE RECONSTITUTION STUDY ONLY: Between 8 and 60 years old
DONOR: Must be >= 14 years old
> 18 years old
Patients must be ? 18 years old.
At least 18 years old;
Man or woman >= 18 years old.
DONOR: Less than 18 years old
Male or female patients from 6 months to ? 21 years old at the time of study enrollment
Patients ?18 year old
Patients must be > 18 years old.
Donor: Donor < 6 months old, > 75 years old
The patient is ? 18 years old.
The patient is ? 18 years old.
Participants who are 16 to 17 years old would be enrolled after consultation with the Medical Monitor
Are a male or female patient ?18 years old.
DONOR: Children < 12 years old
Adult Women (? 18 years old).
Be 18 years old at the time the informed consent is signed
?18 years old.
Patient must be ? 18 years old.
Patients must be at least 18 years old.
Men and women ?18 years old.
Are a male or female participants ?18 years old.
Patients ? 16 years old
Patient must be at least 18 years old.
Male or female patients ?18 years old.
Patients 18 years old or greater
Patients > or = 18 years old
? 18 years old at the time of informed consent.
Patients must be >/= 18 years old.
?18 years old
?18 years old
Male or female ?18 years old
Donor >= 18 years old
Male or female patient is ? 18 years old,
Male and female TAM patients ? 2 years old at the time of first dose administration. Patients < 12 years old can only be included in the study after first IA has shown that it is safe and well tolerated in patients ? 12 years old (Section 3.5).
Male or female patients ? 18 years old
Is >18 years old;
Male or female ?18 years old.
Patient is an adult, female ? 18 years old at the time of informed consent
? 18 years old
Men or women > 18 years old
?18 years old, diagnosed with persistent or chronic ITP
Man or woman >= 18 years old.
Subjects >=18 years old.
? 18 years old Part 2, dose expansion:
Is the subject between 18 years old and 80 years old inclusive?
The subject is at least 18 years old.
Patient is an adult ? 18 years old at the time of informed consent.
18-39 years old
Men or women > 18 years old
The patient is ?18 years old.
?18 years old
In patients > 60 years old, documented LVEF of less than or equal to 45%
Patients must be greater than or equal to 18 years old.
Men or women ?18 years old
Male or female patients ?18 years old.
Men or women ? 18 years old
For patients < 60 years old: at least two induction chemotherapy treatments.
For patients >= 60 years old: at least one induction chemotherapy treatment or alternative treatment.
Females at least 18 years old;
Male or female patients >= 18 years old
Patients treated at collaborating sites and current St. Jude patients who are on therapy or within 3 years of completion of therapy must be =< 24 years old; all other St. Jude patients must be =< 21 years old
Subject is female and is at least 18 years old
DCG: Is an adult family member (at least 18 years old) of a patient with an advanced-stage cancer
< 19 years old
< 19 years old
CAREGIVERS ONLY: Must be an adult (>=18 years old)
Are at least 18 years old
Are 8-17 years old
Patients who are in close social contact with children under 5 years old
Adult (?18 years old)
18-35 years old
Male 18 to 60 years old
Female 18 to 50 years old
18-40 years old,
The patient is ?21 years old,
>18 years old.
FLT PET: will only be performed in patients >= 10 years old
Research biopsies in consenting patients with MPNST: will only be performed in patients >= 18 years old
Patient is < 18 years old at the time of the drug administration
?18 years old
M/F at least 18 years old
History of treatment for cancer or related illness diagnosed at =< 25 years old
The patient is at least 18 years old.
Women ? 18 years old
Male or female patients aged ?18 years
Female aged ? 18 years.
Male or female patients aged ? 18 years.
Female subject aged ? 18 years.
Male or female aged ? 18 years
Adult male or female participants aged >=20 years (Japan) or >=18 years (United States).
Male or female patients aged ? 18 years at time of informed consent;
Male or female aged ? 18 years;
Male or female aged ?18 years.
Male or female, aged at least 18 years.
Female, aged ?18 years
Male or female subjects aged greater than or equal to (>=) 18 years
Male or female subjects aged ?18 years
Male or non-pregnant, non-breastfeeding female at least 18 years of age. Patients aged at 12~18 years may be recruited but only at the site principle investigator's request and subject to IRB approval.
Male or female aged at least 18 years. Aged at least 20 if Japanese.
Male patient aged, equal to, or more than,18 years old.
Male or female patients aged 18 - 75 years.
Male or female subjects aged greater than or equal to (>=) 18 years
Male or female subjects aged ?18 years
Subjects may be male or female, and must be aged =/>18 years on the date of signing the informed consent form.
Male or female subjects aged ?18 years
Male or female subjects aged >/= 18 years.
Patient is male or female aged ?18 years.
Male or female, aged at least 18 years.
Male or female subjects aged greater than or equal to (>=) 20 years
Male and female subjects aged greater than 18 years
Male or female patients aged >/= 18 years old
Male or female participants aged ?18 years at the time of screening
Male or female subjects aged > 18 years
Male and female subjects aged 1 to 18 years, inclusive.
Male or female aged ? 18 years
Male or female subjects aged ?18 years (or country-specific legal age of maturity, if >18 years)
Male or female subjects aged =/> 18 years
Male or female subjects aged >/=18 years
Male or female aged ? 18 years
Male or female subjects aged >/=21 years
Male and female patients aged ? 18 years.
Male or female participants aged 2 to <18 years (5 to <18 years for Hodgkin lymphoma [HL])
Male or female aged 16 years; a female is eligible to enter and participate in the study if she is:
Male or female patients aged >18 years
Male and female patients aged 18 to 70 years, inclusive;
Female aged ?18 years of age.
Male or female, age ? 18 years and ? 70 years. Patients aged ? 65 years must have a Sorror score ? 3
Male or female aged 18-79
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n* Age 1 to < 2 years: maximum serum creatinine (mg/dL) 0.6 for males and females\r\n* Age 2 to < 6 years: 0.8 for males and females\r\n* Age 6 to < 10 years: 1 for males and females\r\n* Age 10 to < 13 years: 1.2 for males and females\r\n* Age 13 to < 16 years: 1.5 for males and 1.4 for females\r\n* Age >= 16 years: 1.7 for males and 1.4 for females
Participants must be skeletally mature defined as females with a bone age >= 15 years and males with a bone age >= 17 years
Males or females age greater than or equal to 18 years at the time of informed consent
Males or females who are 18 years or older
Males and females of any age
Males or females, ?18 years of age
Males or females age ? 18 years at the time of informed consent
Males and Females at least 18 years of age
Adult males or females aged 18 years or over
Males and females ? 18 years of age at screening
Are males or females aged ? 18 years
Males and females 12 years old or older
Males and females ? 18 years of age.
Males and females 18 years old or older.
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73^2 or serum creatinine based on age/gender as follows:\r\n* Age 1 month to < 6 months: 0.4 for males and 0.4 for females\r\n* Age 6 months to < 1 year: 0.5 for males and 0.5 for females\r\n* Age 1 to < 2 years: 0.6 for males and 0.6 for females\r\n* Age 2 to < 6 years: 0.8 for males and 0.8 for females\r\n* Age 6 to < 10 years: 1 for males and 1 for females\r\n* Age 10 to < 13 years: 1.2 for males and 1.2 for females\r\n* Age 13 to < 16 years: 1.5 for males and 1.4 for females\r\n* Age >= 16 years: 1.7 for males and 1.4 for females\r\n** Participants with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
STRATUM C: Participant must be skeletally mature as defined as females with a bone age > 15 years and males with a bone age > 17 years
Males or females ?18 years of age.
Males ? 18 years of age on the day of consenting to the study.
Males and Females, age ? 18 years old
Males and Females, age ? 18 years old
Males or females aged ? 20 years and < 75 years
Males and females >=18 years of age (at the time consent is obtained)
Males and females ? 18 years of age
Males and females ? 18 years of age
Normal creatinine phosphokinase (CPK) defined as not exceeding maximum value listed below :\r\n* Age: 0 to < 4 years; 305 units/L for males and 305 units/L for females\r\n* Age: 4 to < 7 years; 230 units/L for males and 230 units/L for females\r\n* Age: 7 to < 10 years; 365 units/L for males and 365 units/L for females\r\n* Age: 10 to < 12 years; 215 units/L for males and 230 units/L for females\r\n* Age: 12 to < 14 years; 330 units/L for males and 295 units/L for females\r\n* Age: 14 to < 16 years; 335 units/L for males and 240 units/L for females\r\n* Age: 16 to < 19 years; 370 units/L for males and 230 units/L for females\r\n* Age: >= 19 years; 170 units/L for males and 145 units/L for females
Serum creatinine < 2 x upper limit of normal (ULN) for age\r\n1 to < 2 yrs males: 0.6 females: 0.6\r\n2 to < 6 yrs males: 0.8 females: 0.8\r\n6 to < 10 yrs males: 1 females: 1\r\n10 to < 13 yrs males: 1.2 females: 1.2\r\n13 to < 16 yrs males: 1.5 females: 1.4\r\n17 to 20 yrs males: 1.7 females: 1.4\r\nOver 21 yrs males: 2 x ULN females: 2 x ULN
Males and females at least 18 years of age.
Age 18 years or older, males and females.
Males or females 21 years or older
Criteria 2 Males or females ? 18 years of age
Males and females, age ?18 and ? 65 years of age
Males and females, age ?18 and ? 75 years of age
Males or females ? 18 years of age at screening.
Males or females at least 18 years of age
Males or females aged ?18 years at screening.
Males and females ? 18 years of age
- Males and females at least 18 years of age
- Males and females ? 18 years of age
Female subjects age >= 18 years (males with breast cancer are eligible)
Patients must be males ? 18 years of age
A serum creatinine =< upper limit of normal (ULN) based on age/gender as follows:\r\n* Age 1 month to < 6 months: 0.4 for males, 0.4 for females\r\n* Age 6 months to < 1 year: 0.5 for males, 0.5 for females\r\n* Age 1 to < 2 years: 0.6 for males, 0.6 for females\r\n* Age 2 to < 6 years: 0.8 for males, 0.8 for females\r\n* Age 6 to < 10 years: 1 for males, 1 for females\r\n* Age 10 to < 13 years: 1.2 for males, 1.2 for females\r\n* Age 13 to < 16 years: 1.5 for males, 1.4 for females\r\n* Age >= 16 years: 1.7 for males, 1.4 for females
Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent
Males and females 18 years old and greater
Males and females ? 18 years old
Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent (Screen 1).
Males and females aged ?18 years;
Males and females age ?18 years
Males and females ? 18 years of age
Males and females ? 18 years of age;
Males or females ? 18 years of age
Males and females ?18 years of age
Subjects must be males or females age 18 years or older.
Males and females age ? 18 yrs;
Males and females >=18 years of age (at the time consent is obtained).
Males and females ?18 years of age for NSCLC, TNBC, and CRPC
Males and females ?16 years of age for NMC
Males 18 years of age and above
Males or females
Males and females >=18 years of age (at the time consent is obtained).
Males or females, age 18 years or older.
Males and females ?18 years of age (at the time consent is obtained);
Males and postmenopausal females, 18 years or older
Glomerular filtration rate >= 60 cc/min/1.73 m^2, or serum creatinine based on age as follows:\r\n* Age 1 to 2 years: 0.6 for males and 0.6 for females\r\n* Age 2 to 6 years: 0.8 for males and 0.8 for females\r\n* Age 6 to 10 years: 1 for males and 1 for females\r\n* Age 10 to < 13 years: 1.2 for males and 1.2 for females\r\n* Age 13 to 16 years: 1.5 for males and 1.4 for females\r\n* Age > 16 years: 1.7 for males and 1.4 for females
Males and females ? 18 years of age.
Males or females of any race at least 18 years of age
Males age ? 18 years
Skeletally mature adult males and females 18 years of age or older.
Males or females at least 18 years of age
Males and females ? 18 years of age
Males and females >=18 years of age (at the time consent is obtained).
Males and females ? 18 years of age
Males and females >= 18 years of age
Males and females 18 years of age and older at the time of screening
Males / females, ? 18 years old, any race / ethnicity, who can provide written Informed Consent
Males and females ? 18 years of age
5. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.
Males and females of any age
Males and females greater than or equal to 18 years of age
Males and females ? 18 years of age.
Age greater than or equal to (>=) 18 years, including males and females;
Males or females aged greater than or equal to 18 years at the time of informed consent.
Males ? 18 years of age
Males and females of 18 to 89 years of age.
Males and Females, ages 18 and older
Males age ? 18 years
Males or females aged ?18 years on day of consent.
Males will be excluded.
Males or females, aged between 50 and 75.
Males and females,age 1 year(365 days) to < 18 (17 years and 364 days) years.
Males and females aged ? 1.0 year and < 66.0 years
2. Males or females aged ?18 years;
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows: NOTE: for MRI imaging serum creatinine measurement must meet the same criteria and be measured within 1 week of the imaging session\r\n* Age 1 month to < 6 months: 0.4 for males; 0.4 for females\r\n* Age 6 months to < 1 year: 0.5 for males; 0.5 for females\r\n* Age 1 to < 2 years: 0.6 for males; 0.6 for females\r\n* Age 2 to < 6 years: 0.8 for males; 0.8 for females\r\n* Age 6 to < 10 years: 1.0 for males; 1.0 for females\r\n* Age 10 to < 13 years: 1.2 for males; 1.2 for females\r\n* Age 13 to < 16 years: 1.5 for males; 1.4 for females\r\n* Age >= 16 years: 1.7 for males; 1.4 for females
Males or females age ?18 years at the time of informed consent.