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Clinical Trial News

AI Decision Support Tool Shows No Improvement in Cardiovascular Outcomes for Chest Pain Patients

  • The RAPIDxAI trial assessed an AI tool's impact on managing emergency department patients with elevated high-sensitivity cardiac troponin (hs-cTn).
  • The study found no significant difference in the composite of cardiovascular death, myocardial infarction, and unplanned CV readmission at 6 months between the AI and standard care groups.
  • The AI-based tool improved adherence to evidence-based therapies like statins and antiplatelet agents without increasing short-term adverse events.
  • The AI algorithm showed potential in reinforcing guideline-directed medical therapies for type 1 myocardial infarction, suggesting future refinement and cost-effectiveness evaluations are needed.

Iovance's MDA-TIL Trial Terminated, Sention's ST-1891 Phase II Completed

  • Iovance Biotherapeutics' MDA-TIL Phase II trial was terminated due to lack of efficacy, significantly decreasing its Phase Transition Success Rate (PTSR) in ovarian, colorectal, and pancreatic cancers.
  • Sention Therapeutics' ST-1891 Phase II trial in hypothyroidism was completed, leading to a nine-point increase in the drug's PTSR, reaching 22% for this indication.
  • Karyopharm Therapeutics' Xpovio (selinexor) Phase II trial in metastatic melanoma was terminated due to insufficient anti-tumor activity, resulting in a 14-point PTSR decrease to 11%.
  • Armata Pharmaceuticals' APPA-02 Phase II trial in bronchiectasis was completed, increasing the drug candidate’s PTSR by seven points to 43%.

FRDA Investigator Initiated Study (IIS) With Elamipretide

NCT05168774CompletedPhase 1
Children's Hospital of Philadelphia
Posted 3/3/2022

Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection

NCT05616221CompletedPhase 2
Armata Pharmaceuticals, Inc.
Posted 1/10/2023

Phase 2 Study to Assess Efficacy & Safety of WP1302 Prevent Relapse of MMI w/Draw in Subj. w/ Graves' dz

NCT06240455SuspendedPhase 2
Worg Biotherapeutics Inc.
Posted 3/31/2026

A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

NCT05412979CompletedPhase 2
Sention Therapeutics, LLC
Posted 4/29/2022

Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma

NCT03610490TerminatedPhase 2
M.D. Anderson Cancer Center
Posted 10/16/2018

Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma

NCT04768881TerminatedPhase 2
Karyopharm Therapeutics Inc
Posted 5/12/2021

Medtronic's Aurora EV-ICD Shows Sustained Long-Term Safety and Efficacy

  • Medtronic's Aurora EV-ICD system demonstrates sustained safety and effectiveness in preventing sudden cardiac death over an average of 30.6 months.
  • The study highlights successful anti-tachycardia pacing (ATP) in 77% of episodes, reducing the need for painful shocks and improving patient quality of life.
  • Data indicates a low major complication rate and high therapy success, with increased ATP utilization over the study duration, benefiting patients.
  • Patients reported fewer body image concerns and greater overall acceptance of the EV-ICD compared to subcutaneous ICDs, showcasing improved device satisfaction.

Sanofi's Tolebrutinib Meets Primary Endpoint in Phase 3 Relapsing MS Trial

  • Sanofi's oral treatment, tolebrutinib, achieved its primary endpoint in a Phase 3 study for relapsing multiple sclerosis (MS).
  • The positive results may pave the way for regulatory approval of tolebrutinib as a treatment option for MS patients.
  • Sanofi executives express confidence that the positive trial outcome validates their research and development efforts.
  • Earlier studies of tolebrutinib in patients with less advanced MS did not demonstrate a statistically significant benefit.

Solvent Detergent-Treated IVIG Demonstrates Absence of Hypotensive Effects in Clinical Trials

• Clinical trials evaluating a new solvent detergent-treated intravenous immunoglobulin (IVIG) were conducted to assess its safety profile. • The study focused on monitoring patients for hypotensive responses during IVIG infusion to ensure patient safety. • Results indicated that the modified IVIG production process did not induce hypotension in either animal models or human clinical trials. • The findings suggest that the solvent detergent treatment does not damage IgG or create vasoactive kinins.

AI-Assisted Heart Scans Show Promise for Less Experienced Clinicians in PROTEUS Trial

  • The PROTEUS trial evaluated AI's role in stress echocardiogram interpretation for patients with suspected coronary artery disease, showing no significant difference in the primary endpoint.
  • AI assistance may improve decision-making among less experienced clinicians and in subgroups with challenging-to-interpret images.
  • The study suggests AI could potentially standardize accuracy levels across clinicians with varying experience in stress echocardiogram interpretation.
  • The PROTEUS trial enrolled 2,341 patients across 20 UK hospitals to compare standard clinical decision-making versus AI-augmented decision-making.

MRD Status Linked to Progression-Free Survival in CLL: Meta-Analysis

  • A meta-analysis of 11 clinical trials reveals a strong association between undetectable minimal residual disease (MRD) and improved progression-free survival (PFS) in CLL patients.
  • Patients with undetectable MRD at 0.01% showed a significantly reduced risk of disease progression (HR, 0.28; P < .001) compared to those with detectable MRD.
  • Undetectable MRD was associated with improved PFS in both frontline and relapsed/refractory CLL settings, as well as in patients receiving time-limited therapy.
  • The study suggests MRD status could serve as an endpoint in clinical trials, potentially accelerating drug registration for CLL treatments.

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT02048813Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 3/10/2014

Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

NCT02301156CompletedPhase 3
TG Therapeutics, Inc.
Posted 1/27/2015

A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

NCT01905943CompletedPhase 3
Hoffmann-La Roche
Posted 11/4/2013

A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion

NCT01889186CompletedPhase 2
AbbVie
Posted 6/27/2013

Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation

NCT02950051CompletedPhase 3
German CLL Study Group
Posted 12/13/2016

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT03462719Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 4/17/2018

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

NCT02005471CompletedPhase 3
Hoffmann-La Roche
Posted 3/17/2014

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

NCT01010061CompletedPhase 3
Hoffmann-La Roche
Posted 12/21/2009

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT02264574CompletedPhase 3
Pharmacyclics LLC.
Posted 10/6/2014

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

NCT02242942Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2014

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT01611090CompletedPhase 3
Janssen Research & Development, LLC
Posted 9/19/2012

Voriconazole MIC Levels Linked to Poorer Outcomes in Fusarium Keratitis

  • Analysis of fungal keratitis cases reveals no overall association between antifungal MICs and clinical outcomes.
  • In Fusarium-positive cases, elevated voriconazole MIC correlates with increased need for therapeutic penetrating keratoplasty.
  • Higher voriconazole MICs in Fusarium infections also linked to worse three-month visual acuity and prolonged re-epithelialization time.
  • Natamycin MIC was not found to be a significant predictor of any of the studied clinical outcomes among organism subgroups.

OCT-Guided PCI Improves Outcomes in Complex Coronary Lesions: OCCUPI Trial

  • The OCCUPI trial demonstrated that optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI for cardiovascular outcomes in complex coronary lesions.
  • At 12 months, OCT-guided PCI significantly reduced major adverse cardiac events (MACE), driven primarily by a reduction in ischemia-driven target lesion revascularization (ID-TLR).
  • While OCT-guided PCI improved outcomes, it was associated with greater contrast volume use and longer procedural duration compared to angiography-guided PCI.

REC-CAGEFREE I: Drug-Coated Balloon Angioplasty Fails to Meet Noninferiority Criteria Compared to DES

  • The REC-CAGEFREE I trial assessed paclitaxel-coated balloon (DCB) angioplasty against drug-eluting stents (DES) in patients with de novo coronary artery lesions.
  • The study found DCB angioplasty did not meet noninferiority criteria compared to DES for cardiovascular outcomes at 2 years, showing potential inferiority.
  • DCB angioplasty showed comparable outcomes to DES in small vessel disease, but was inferior in larger vessels, suggesting vessel size impacts treatment efficacy.
  • The trial highlights the need for further research to confirm the role of DCB in specific patient subgroups, especially considering varying paclitaxel dosages.

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