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Hemophilia Foundation of Northern California
Research interests focus on the clinical care and treatment of children with disorders in 2 clinical areas 1) histiocytic disorders, such as Langerhans cell histiocytosis, and hemophagocytic lymphohistiocytosis, and 2) vascular anomalies and malformations.
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause
lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a
cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes
there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF
gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells
to build up in certain parts of the body, where they can damage tissue or form lesions.
For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line
therapy while cytarabine therapy has been used as therapy for patients who develop
recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.
The purpose of this research study is to compare previously used vinblastine/prednisone to
single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study
called a positron emission tomography (PET) scan to more accurately assess areas of LCH
involvement not otherwise seen in other imaging studies as well as response to therapy. We
also want to identify if genetic and other biomarkers (special proteins in patient's blood
and in patient's cancer) relate to the response of patients LCH to study treatment.
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Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint
evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is
designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to
compare the efficacy and safety of edoxaban against standard of care in pediatric subjects
with confirmed VTE.
A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components
This study is a prospective, non-randomized sequential cohort, open label, multi-center,
non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The
patient population will be hematology-oncology patients, including those undergoing
hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions.
For each participating center, the study will start with a brief pilot run-in period with a
group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot
run-in is to evaluate study logistics and data collection methods within each study center.
Data from the pilot phase will be included in the data analysis for the treatment comparison.
After the pilot run-in period, the study will be conducted in two sequential patient cohorts:
1) the Control cohort during which study patients will receive only conventional PCs, and 2)
the INTERCEPT cohort during which patients will receive only INTERCEPT PCs. Patient
enrollment at each Center will be monitored to target similar numbers of patients into the
Control and Test Cohorts within each center. Centers may enroll Control and Test patients in
ratios that vary from 2:1 to 1:2 due to institutional requirements to move rapidly to full
INTERCEPT implementation, or due to availability issues with either Test or Control
components. Within each Center, patient enrollment will be stratified in four categories: (1)
chemotherapy only; and by use of conditioning regimens for hematopoietic stem cell
transplantation (HSCT) in (2) myeloablative conditioning, (3) non-myeloablative conditioning,
and (4) reduced intensity using the Center for International Blood and Marrow Transplant
Research (CIBMTR) criteria. Note time from last chemotherapy treatment to first study
transfusion should be no more than 30 days. To ensure both Test and Control cohorts have a
similar allocation ratio (±10% per category) among the conditioning regimen strata,
enrollment caps will be set for the Test cohorts, hence no Test patients will be enrolled to
a stratum once the cap for the given stratum is met. Eligible patients will be enrolled in
open Test strata sequentially as long as there is sufficient Test PC inventory available.
Enrollment may be delayed for the Test cohort if sufficient inventory of Test PCs is not
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a
single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy
to see what the body does to the drug (pharmacokinetics) and what the drug does to the body
(pharmacodynamics), and to compare if these effects are similar to those observed in adults.