Clinical trials: Phase 1
Epilepsy
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
- Trial name
- NCT05076838
- Testing
- Diazepam Nasal Spray [Valtoco]
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Neurelis, Inc.
Medulloblastoma, Childhood, Medulloblastoma Recurrent
Testing the Safety and Tolerability of CX-4945 in Patients With Recurrent Medulloblastoma Who May or May Not Have Surgery
This is a multi center, Phase I, Phase II and surgical study of the CX-4945 drug (silmitasertib sodium) for patients with recurrent SHH (Sonic Hedgehog) medulloblastoma
- Conditions
- Medulloblastoma, Childhood, Medulloblastoma Recurrent, Medulloblastoma
- Trial name
- NCT03904862
- Testing
- CX 4945
- Where
- 12 sites in United States
- Volunteers
- 21 people
- Sponsor
- Pediatric Brain Tumor Consortium
Refractory Acute Lymphoblastic Leukemia, Relapsed Acute Lymphoblastic Leukemia
Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) and assessing the…
- Trial name
- NCT05192889
- Testing
- Venetoclax, Navitoclax, Dexamethasone
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- St. Jude Children's Research Hospital
Acute Myeloid Leukemia (AML)
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children.
- Trial name
- NCT06679582
- Testing
- Luveltamab tazevibulin
- Where
- 36 sites in United States, Austria and 7 more
- Volunteers
- 1 people
- Sponsor
- Sutro Biopharma, Inc.
Cerebral Palsy
Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy
The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group.
- Trial name
- NCT05336227
- Testing
- Virtual Reality Exergaming
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Cancer
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol).
- Trial name
- NCT01542879
- Testing
- WB-DW-MR scan, 18-F-FDG PET scan, Ferumoxytol
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- Stanford University
Hodgkin Disease, Lymphoma
Administration of T Lymphocytes for Prevention of Relapse of Lymphomas
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells.
- Conditions
- Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin, Immune System Diseases
- Trial name
- NCT02663297
- Testing
- ATLCAR.CD30 cells
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Glioblastoma Multiforme, Anaplastic Astrocytoma
INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas
This is a multicenter phase 1 trial of INCB7839 for children with recurrent or progressive high-grade gliomas, including, but not limited to, diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), after…
- Conditions
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, DIPG
- Trial name
- NCT04295759
- Testing
- INCB7839
- Where
- 11 sites in United States
- Volunteers
- 13 people
- Sponsor
- Pediatric Brain Tumor Consortium
Biliary Atresia
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after…
- Trial name
- PRIME (NCT01854827)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Recurrent Anaplastic Large Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma
Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas
This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer [NK] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30…
- Conditions
- Recurrent Anaplastic Large Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Classic Hodgkin Lymphoma, Recurrent Mycosis Fungoides
- Trial name
- NCT04074746
- Testing
- Anti-CD30/CD16A Monoclonal Antibody AFM13, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- M.D. Anderson Cancer Center
Pediatric Cancer, Solid Tumor Pediatric
Durvalumab and Tremelimumab for Pediatric Malignancies
The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the…
- Conditions
- Pediatric Cancer, Solid Tumor Pediatric, Hematological Malignancies
- Trial name
- NCT03837899
- Testing
- Durvalumab / Tremelimumab Combination Therapy
- Where
- 19 sites in United States, France and 5 more
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Sickle Cell Disease, Pulmonary Hypertension
Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension
The goal of this study is to test the hypothesis that hydroxyurea is effective for the specific treatment of secondary pulmonary hypertension found on screening in children and young adults with sickle cell disease.
- Trial name
- NCT00350844
- Testing
- Hydroxyurea
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Bronchiolitis Obliterans
Hp129 Xenon Imaging and BOS in Lung Transplantation
The research is being conducted to develop new imaging methods that are sufficiently sensitive to allow for early diagnosis of BOS, a chronic allograft rejection affecting 50-60% of lung transplanted recipients who survive 5…
- Trial name
- NCT03603899
- Testing
- Hp 129Xenon
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Human Metapneumovirus, Human Parainfluenza Virus Type 3
Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age
HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to < 60 months of…
- Trial name
- NCT06546423
- Testing
- B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Autism Spectrum Disorder, Gastrointestinal Symptoms
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day…
- Trial name
- NCT03514784
- Testing
- BB-12 with LGG (Higher Dose), BB-12 with LGG (Lower Dose)
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Leukemia, Lymphoma
A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically…
- Trial name
- NCT04571138
- Testing
- SCRI-CAR22v2
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Seattle Children's Hospital
Amyotrophic Lateral Sclerosis, Frontotemporal Dementia
Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)
This is an OLE study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of WVE-004 in adult participants with ALS, FTD, or mixed ALS/FTD phenotype with a documented…
- Trial name
- NCT05683860
- Testing
- WVE-004 10 mg Q12W
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 8 people
- Sponsor
- Wave Life Sciences USA, Inc.
Congenital Hemolytic Anemia, Sickle Cell Disease
Improving the Results of Bone Marrow Transplantation for Patients With Severe Congenital Anemias
People with severe congenital anemias, such as sickle cell anemia and beta-thalassemia, have been cured with bone marrow transplantation (BMT).
- Trial name
- NCT00061568
- Testing
- Peripheral blood hematopoietic progenitor cell (PBPC) transplant, Alemtuzumab, Peripheral blood hematopoietic progenitor cell Apheresis
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hematopoietic Stem Cell Transplant
Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients
High dose chemotherapy and radiation used as preparative regimens in patients undergoing an allogeneic hematopoietic stem cell transplant (HSCT) disrupts intestinal homeostasis by damaging the intestinal epithelium and altering…
- Trial name
- NCT04263597
- Testing
- 2'-fucosyllactose
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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