Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Recruiting
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Gender:
ALL
Ages:
Between 0 years and 20 years
Trial Updated:
03/11/2025
Locations: University of Florida Jacksonville Shands Medical Center, Jacksonville, Florida
Conditions: Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis; Hemorrhage, Hemophilia, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
Completed
This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, e... Read More
Gender:
ALL
Ages:
364 days and below
Trial Updated:
02/26/2025
Locations: Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida +12 locations
Conditions: Acute Leukemia of Ambiguous Lineage, B Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib
Active Not Recruiting
This phase II trial studies how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) but is not resistant to bortezomib (refractory). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
02/11/2025
Locations: Mayo Clinic in Florida, Jacksonville, Florida
Conditions: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Active Not Recruiting
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is no... Read More
Gender:
ALL
Ages:
Between 1 year and 30 years
Trial Updated:
02/01/2025
Locations: Broward Health Medical Center, Fort Lauderdale, Florida +17 locations
Conditions: T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma
S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma
Completed
This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
11/26/2024
Locations: University of Florida, Gainesville, Florida +2 locations
Conditions: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
Active Not Recruiting
This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to co... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
11/13/2024
Locations: Mayo Clinic- Site Number : 8400008, Jacksonville, Florida +1 locations
Conditions: Plasma Cell Myeloma Recurrent
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Active Not Recruiting
Primary Objectives: * Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) * Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in Pa... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
10/30/2024
Locations: Cancer Specialist of North Florida Site Number : 8400011, Jacksonville, Florida +1 locations
Conditions: Plasma Cell Myeloma
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
Active Not Recruiting
This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by e... Read More
Gender:
ALL
Ages:
Between 12 months and 21 years
Trial Updated:
10/28/2024
Locations: Broward Health Medical Center, Fort Lauderdale, Florida +13 locations
Conditions: Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Terminated
The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will include a sequential dose exploration part to identify the RP2D of AMG 701 in combination with pomalidomide, with and without dexamethasone... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
10/18/2024
Locations: Mayo Clinic Florida, Jacksonville, Florida
Conditions: Relapsed/Refractory Multiple Myeloma
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Completed
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
Gender:
ALL
Ages:
40 years and above
Trial Updated:
09/12/2024
Locations: Tampa Bay Medical Research, Clearwater, Florida +8 locations
Conditions: Osteoarthritis of the Knee
Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
Recruiting
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of oral cemsidomide (also known as CFT7455) administered at different dosages in subjects with Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM). Cemsidomide may be administered as a single agent and, in MM only, in combination with oral dexamethasone.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/27/2024
Locations: Mayo Clinic, Jacksonville, Florida
Conditions: Multiple Myeloma, Lymphoma, Non-Hodgkin's
Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Completed
This phase I/II trial studies the side effects and best dose of idasanutlin and ixazomib citrate when given together with dexamethasone in treating patients with multiple myeloma that has returned after a period of improvement. Drugs used in chemotherapy, such as idasanutlin and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ixazomib citrate may stop the growth of cancer ce... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/27/2024
Locations: Mayo Clinic in Florida, Jacksonville, Florida
Conditions: Loss of Chromosome 17p, Recurrent Plasma Cell Myeloma