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Infusion Reaction clinical trials

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NCT ID: NCT06031233 Recruiting - Oncology Clinical Trials

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

MINUTE
Start date: September 1, 2023
Phase: Phase 4
Study type: Interventional

This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile. Infusion times will be gradually shortened if tolerability allowes.

NCT ID: NCT04198623 Recruiting - Infusion Reaction Clinical Trials

Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions

Start date: March 20, 2020
Phase: Phase 2
Study type: Interventional

The use of monoclonal antibodies (MA) either alone or as part of chemoimmunotherapy in oncology, benign and malignant hematology is expanding. Of the 17 therapeutic MAs approved in 2017 by FDA, 50% of them are indicated for hematologic and oncologic condition. With increasing number of approved agents, therapeutic MAs have become one of the fastest growing areas in the management of benign and malignant hematologic condition. Advancement of recombinant technology allows development of partially or fully humanized new agents. Despite this, they still carry significant risk of immune and non-immune mediated adverse events. Most of the therapeutic monoclonal antibody related adverse events (MCAAE) The severity of reaction is variable, ranging from mild involvement of single organ to severe and life-threatening reactions requiring hospitalization or even resulting in death. Even for mild infusion reactions, where re-initiation of infusion is possible, there is resultant delay in delivery of infusions, distress to patients, and additional utilization of health care resources. Due to unpredictability of standard infusion reaction (SIR), efforts have been focused on premedication to decreasing the incidence and severity of infusion reaction. Most institutions have protocols using corticosteroid, acetaminophen and antihistamine as part of their premedication protocols. This has reduced but not eliminated standard infusion reactions. Most recently, mast cell stabilizers are being added to standard protocols to further reduce the incidence and severity of standard infusion reactions with variable anecdotal success without formal study. Of all the monoclonal antibodies, only Daratumumab has been evaluated using this strategy. This study seeks to evaluate the efficacy of mast cell stabilizer Montelukast (SINGULAIR) 10 mg in decreasing the SIR in patients receiving therapeutic MAs either alone or as part of chemoimmunotherapy in hematologic condition. The MAs being studied includes: Blinatumomab (BLINCYTO, Amgen Inc.), Daratumumab (DARZALEX, Janssen Biotech, Inc.), Elotuzumab (EMPLICIT, Bristol-Myers Squibb Company), Gemtuzumab (MYLOTARG, Pfizer Inc.), Obinutuzumab (GAZYVA, Genentech USA, Inc.), and Rituximab (RITUXAN, Genentech US); The investigators postulate that 10 mg of Montelukast, when given in addition to standard premedication, will lead to decrease in incidence of MA associated SIR, shorter infusion time and decrease use of additional health care resources

NCT ID: NCT04175834 Completed - Multiple Sclerosis Clinical Trials

Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab

PRECEPT
Start date: February 5, 2020
Phase: Phase 3
Study type: Interventional

This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in Infusion-Related Reactions (IRRs) in subjects receiving ocrelizumab(OCR) for multiple sclerosis (MS).

NCT ID: NCT01156090 Completed - Infusion Reaction Clinical Trials

A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Start date: June 2010
Phase: N/A
Study type: Observational

The purpose of this study is to identify approximately 100 - 150 patients who have received Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South Carolina, and North Georgia from February 2004 - April 2009. Information regarding the incidence and severity of hypersensitivity infusion reactions to Vectibix (Panitumumab)will be captured. In patients who experienced hypersensitivity reactions, the following information will also be collected: premedication, treatment cycle symptoms that were experienced during chemotherapy, changes required in subsequent Vectibix (Panitumumab) or chemotherapy treatment, and outcome of the hypersensitivity reaction.