This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-optimization study to evaluate the safety and clinical activity of PBCAR0191 in adults with r/r B ALL (Cohort A) and in adults with r/r B-cell NHL (Cohort N) and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two arm trial with an adaptive design. Eligible subjects will be randomized in a 1:1 ratio to PCI with Impella CP® (Intervention Group) versus standard of care PCI with or without IABP (Control Group). Approximately 1252 subjects will be randomized in a 1:1 ratio to PCI + Impella vs. PCI ± IABP.
Cardiogenic shock (CS) is a dangerous clinical condition where the heart’s ability to pump blood is so compromised that it cannot support the vital functions of the rest of the body. CS has an increased risk of death of 50-60%, and despite tremendous research effort over the last decade, survival outcomes have not changed over this period. Current treatment for CS often involves mechanical circulatory support (MCS) devices, which are mechanical pumps that help support blood flow to the body.
The purpose of this randomized study is to evaluate the safety and effectiveness of EVAHEART 2 Implantable Left Ventricular Assist System (EVA2 LVAS) by demonstrating non-inferiority to HeartMate 3 when used for the treatment of advanced, refractory, New York Heart Association Class IV heart failure.
Severe skeletal muscle loss (wasting) and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low or high dose protien supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition.
The purpose of the study is to develop risk profile for unplanned or urgent healthcare use for symptoms of Heart Failure (HF). Patients with HF are hospitalized frequently to manage increasing symptoms. It is important to identify and treat those at highest risk for readmission.
Multi-center, observational post-approval registry to compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period. The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD donor hearts.
This study aims to learn more about the investigational drug, ASTX727, and another drug, venetoclax, when given in combination. It also aims to evaluate potential pharmocokinetics (PK) interactions for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy.
