Clinical trials: Pediatric Tumor
Ulcerative Colitis
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
Pediatric ALL
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
- Trial name
- NCT04851717
- Testing
- Remimazolam
- Where
- 8 sites in United States, Denmark
- Volunteers
- 100 people
- Sponsor
- Acacia Pharma Ltd
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
Pulmonary Relapse of Osteosarcoma
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.
- Trial name
- NCT01650090
- Testing
- Inhaled Lipid Cisplatin (ILC)
- Where
- 15 sites in United States
- Volunteers
- 28 people
- Sponsor
- Eleison Pharmaceuticals LLC.
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment…
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, Pediatric Cancer
- Trial name
- NCT07770698
- Testing
- sonrotoclax, Azacitidine, Inotuzumab ozogamicin
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
Melanoma Stage III, B-cell Non Hodgkin Lymphoma
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.
- Conditions
- Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL, Childhood Non-Hodgkin Lymphoma
- Trial name
- LONGSAFE (NCT06508775)
- Testing
- MB-CART19.1, MB-CART20.1, MB-CART2019.1
- Where
- 7 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Miltenyi Biomedicine GmbH
Leukemia
Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended…
- Trial name
- NCT01088984
- Testing
- Bendamustine
- Where
- 50 sites in United States, Australia and 10 more
- Volunteers
- 43 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Neurofibromatosis Type 1
A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1
The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN.
- Trial name
- INSPIRE-NF1 (NCT06541847)
- Testing
- HLX-1502
- Where
- 14 sites in United States
- Volunteers
- 25 people
- Sponsor
- Healx Limited
Ependymoma, Ewing Sarcoma
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children…
- Conditions
- Ependymoma, Ewing Sarcoma, High-grade Glioma, Leukemia and Lymphoma
- Trial name
- PIVOT IO 020 (NCT04730349)
- Testing
- Nivolumab, NKTR-214
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
Leukemia, Lymphoblastic, Acute, Pediatric
Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment…
- Trial name
- NCT00042341
- Testing
- clofarabine (IV formulation)
- Where
- 14 sites in United States
- Volunteers
- 60 people
- Sponsor
- Genzyme, a Sanofi Company
Cancer, Pediatric Cancer
Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors
The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.
- Trial name
- NCT07773454
- Testing
- Zanzalintinib
- Volunteers
- 18 people
- Sponsor
- Exelixis
Chemotherapy Induced Nausea and Vomiting
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.
- Trial name
- NCT01596413
- Testing
- Sancuso, IV granisetron
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Atopic Dermatitis
10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
- Trial name
- PEER (NCT00568997)
- Testing
- Pimecrolimus
- Where
- United States
- Volunteers
- 8,000 people
- Sponsor
- Bausch Health Americas, Inc.
BKV Infection, CMV Infection
Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic…
- Conditions
- BKV Infection, CMV Infection, EBV Infection
- Trial name
- NCT07685457
- Testing
- LB-DTK-MV
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- LucasBio
Solid Tumors
Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors
This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or…
- Trial name
- iMATRIXcobi (NCT02639546)
- Testing
- Cobimetinib
- Where
- 17 sites in United States, France and 5 more
- Volunteers
- 56 people
- Sponsor
- Hoffmann-La Roche
Cerebral Oxygenation, Pediatric ALL
Accuracy Performance Verification of the INVOS™ System in Pediatrics
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
- Trial name
- INCATH (NCT05962905)
- Testing
- Blood sample, INVOS monitoring
- Where
- 5 sites in United States
- Volunteers
- 110 people
- Sponsor
- Medtronic - MITG
Generalized Myasthenia Gravis, gMG
Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis
The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.
- Trial name
- NCT05644561
- Testing
- Ravulizumab
- Where
- 11 sites in United States, Italy and 3 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Pediatric Cancer
TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide
Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year…
- Trial name
- NCT04610736
- Testing
- Temozolomide Oral Suspension
- Where
- 11 sites in France, Germany and 3 more
- Volunteers
- 49 people
- Sponsor
- Orphelia Pharma
Central Nervous System Tumors
Study of BLZ-100 in Pediatric Subjects With CNS Tumors
Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed.
- Trial name
- NCT02462629
- Testing
- BLZ-100
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Blaze Bioscience Inc.
Neuroblastoma, Relapsed Neuroblastoma
67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
- Conditions
- Neuroblastoma, Relapsed Neuroblastoma, Refractory Neuroblastoma
- Trial name
- NCT04023331
- Testing
- 67Cu-SARTATE, 64Cu-SARTATE
- Where
- 8 sites in United States
- Volunteers
- 21 people
- Sponsor
- Clarity Pharmaceuticals Ltd