Folinic Acid for Prevention of Pemetrexed-induced Toxicity

Launched by AMPHIA HOSPITAL · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial, called the FLEX-trial, is studying whether taking folinic acid can help prevent certain side effects caused by a chemotherapy drug called pemetrexed in patients with advanced lung cancer (non-small cell lung cancer), mesothelioma, or thymoma. The main focus is on measuring the level of neutrophils, a type of white blood cell that helps fight infections, in patients who receive pemetrexed with or without folinic acid. The trial involves 50 participants, with half receiving folinic acid and the other half not.

To be eligible for this study, participants must be at least 18 years old, have been prescribed pemetrexed-based chemotherapy, and have a performance score indicating they can carry out daily activities. Patients will receive treatment for four cycles and will take folinic acid for a few days after each pemetrexed dose. The study aims to determine if the addition of folinic acid can reduce the risk of low neutrophil counts and other complications during chemotherapy. If you or someone you know is considering joining this trial, it’s essential to discuss it with a healthcare provider to understand the potential benefits and any risks involved.

Gender

ALL

Eligibility criteria

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• • 1. ≥18 years old
• • 2. Eligible for treatment with pemetrexed-based chemotherapy based on indication.
• • 3. ECOG performance score of 0-2.
• • 4. Subject is able and willing to sign the Informed Consent Form
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• • 1. Contraindications for treatment with folinic acid in line with the SmPC.
• • 1. Hypersensitivity to the active substance or to any of the excipients.
• • 2. Anaemia caused by vitamin B12 deficiency.
• • 2. The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.