Investigating Mechanistic Predictors of Interpatient Variability and Temozolomide (TMZ) Induced Haematological Toxicity for Glioma Patients

NCT06546631 · tracked via the Priya Life Science Ireland tracker

Sponsor

University College Cork

Phase

Observational

Started

2024-08-22

Last updated

2026-03-04

Condition(s) studied

Glioma

Study summary

A medication called temozolomide has been used for many years in the treatment of high-grade gliomas, which are tumours that originate in the brain. While this drug is the normal treatment for high-grade glioma, a number of patients develop a side-effect which results in low levels of some important blood cells, such as platelets or white blood cells. If this side-effect occurs, treatment with temozolomide may have to be stopped or paused, which may affect how well this treatment works.

At present, it is unknown why some patients develop this side effect and others do not. It is known that patients with a higher concentration of temozolomide in their blood are at an increased risk of developing this toxicity. There may be some factors associated with the movement of the drug in the body or the removal of the drug from the body which may affect the concentration of temozolomide in blood. There are many factors which may be involved, including genes, other medicines that are taken, how well kidneys and liver are working or even the microbiome (which is the bacteria in the gut).

This study is being done to find out what these factors could be. In the future, this may lead to medical care teams being able to predict which patients are at higher risk of side-effects, allowing them to implement measures to reduce the risk of this occurring.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Part A Inclusion Criteria: 1. 18 years of age or over 2. Will receive or are currently receiving concurrent phase treatment with TMZ for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma or Glioblastoma). 3. Provision of informed consent to participate. Exclusion Criteria: a. Patients who, in opinion of supervising clinician, are clinically too unwell to provide informed consent or for whom additional blood samples, or other research samples, would not be indicated or appropriate. Part B Inclusion Criteria: 1. 18 years of age or over 2. Receiving or received treatment with TMZ for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma or Glioblastoma). 3. Developed any CTCAE Grade ≥3 Haematological Toxicity associated with Temozolomide, and/or any 1 of: i. Platelet count \<100 x 109/L ii. Neutrophil Count \<1.0 x 109/L iii. Haemoglobin value \<8.0 g/L iv. Omission of daily TMZ dose for ≥3 consecutive days during concurrent phase due to FBC concerns v. Deferral of subsequently due TMZ cycle by ≥7 days during adjuvant phase; vi. Dose reduction or permanent discontinuation of TMZ for reasons of haematological toxicity (as per treating physician discretion); vii. Use of growth factors, platelets or packed-cell transfusions during the course of TMZ. d. Provision of informed consent to participate. Exclusion criteria: a. Patients who, in opinion of supervising clinician, are clinically too unwell to provide informed consent or for whom additional blood samples, or other research samples, would not be indicated or appropriate.

Primary outcome measure(s)

Determine potential predisposing factors for severe haematological toxicity from temozolamide — On study registration
Analysis of pharmacogenes
Determine potential predisposing factors for severe haematological toxicity from temozolamide — Baseline and study completion, an average of 9 months
Microbiome analysis of stool bacterial composition

Trial sites (1)

Facility	City	Region	Status
Cork University Hospital	Cork	Ireland	Recruiting

More University College Cork trials in Ireland

Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial. Starting soon

Microbiome Immunotherapy Neoadjuvant Assessment Recruiting

Intelligent Physiological Monitoring to Predict Preterm Brain Injury Enrolling by invitation

A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction Recruiting

An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development. Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06546631 on ClinicalTrials.gov ↗ ← All trials in Ireland