RecruitingOBSERVATIONAL

Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications

This research is investigating if a condition called 'CHIP' (Clonal Hematopoiesis of Indeterminate Significance) can predict complications in older lymphoma patients undergoing chemotherapy. CHIP involves specific changes in bone marrow cells that become more common with age. Doctors want to see if patients with CHIP are more likely to experience issues such as low blood counts, infections, heart problems, or longer hospital stays during treatment. They also hope to understand if CHIP might explain why some patients don't fully recover their normal blood counts after chemotherapy. The findings could help doctors better prepare for and manage potential side effects, allowing for more tailored and effective treatment plans for individuals.

At a glance

Status

Recruiting

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

188

Start

08 Aug 2019

Estimated completion

01 Sep 2026

Lymphoma Chemotherapeutic Toxicity

What is this study about?

When you have lymphoma and need chemotherapy, doctors always try to give you the best possible treatment. This study is looking into something called 'CHIP', which stands for Clonal Hematopoiesis of Indeterminate Significance. It’s a bit of a complicated name, but in simple terms, it means there are some changes in the cells that make your blood in your bone marrow. These changes are quite common as people get older, and they often don't cause any problems on their own.

However, researchers are wondering if having CHIP might make chemotherapy a bit tougher for some people, especially those aged 60 and over. They want to see if patients with CHIP are more likely to have certain issues, like getting infections more easily, having very low blood counts, experiencing heart problems, or needing to stay in hospital longer during or after their chemotherapy. They're also trying to figure out if CHIP could be why some people find it harder to get their blood counts back to normal after their treatment finishes.

The main goal of this study is to help doctors understand more about why some people react differently to chemotherapy. If they find that CHIP does increase the risk of certain problems, it could mean that in the future, doctors might check for CHIP before you start chemotherapy. This would allow them to tailor your treatment plan more precisely, potentially reducing side effects and helping you get through your treatment more smoothly.

Key takeaways

The study explores gene changes (CHIP) in older lymphoma patients.
It aims to understand if CHIP increases chemotherapy side effects.
Participation involves a simple blood test, no changes to your treatment.
Findings could help personalise future chemotherapy plans.
This research focuses on patients aged 60 and over.

Who may be eligible?

This study is looking for volunteers who are 60 years old or older and have been diagnosed with lymphoma. You would be considered if you are about to start your first or second round of chemotherapy for your lymphoma, which might include common medications like CHOP or CVP, or other similar treatments. The type of lymphoma can vary, so many different kinds are included.

However, you wouldn't be able to join if you have certain other conditions. For example, if you already have a specific type of bone marrow cancer called a myeloid neoplasm, or if your white blood cell count (lymphocytes) is very high. You also wouldn't be eligible if you have serious kidney or liver problems, have HIV, or currently have an active infection.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 60 years old or older?
Do you have a diagnosis of lymphoma?
Are you about to start your first or second round of chemotherapy for lymphoma?
Do you *not* have certain other blood disorders or serious kidney/liver problems?
Do you *not* have HIV or an active infection?

Answer every question to see your result.

What does participation involve?

This study involves having a blood test. The researchers will use this blood sample to check for CHIP. There are no specific visits, extra assessments, or new medications required beyond what your usual medical care for lymphoma would involve. You won't be asked to do anything differently with your chemotherapy treatment. The study mainly involves taking this blood sample and then the research team will follow your progress during and after your standard chemotherapy treatment, collecting information from your existing medical records over time. The total duration of your involvement will depend on how long your treatment and recovery takes, as they will be observing how you respond to chemotherapy.

Potential risks and benefits

Taking part in this study primarily involves providing a blood sample during your existing medical care, so there are minimal additional risks beyond those associated with a standard blood draw (e.g., slight bruising or discomfort). The potential benefit is that the findings could lead to a better understanding of how chemotherapy affects different people, possibly helping future patients receive more personalised and safer treatments. There's no direct benefit to you personally during your treatment, as it won't change your current care. Remember, you can choose to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'CHIP'?

CHIP refers to minor changes in the cells that make your blood in the bone marrow, which become more common as you age. They often don't cause problems on their own.

Why is this study important?

It could help doctors understand why some older lymphoma patients have more difficulties with chemotherapy, leading to more tailored and safer treatments in the future.

Will taking part change my chemotherapy?

No, your chemotherapy treatment will remain exactly the same as planned by your medical team.

What does the study involve for me?

You would only need to provide a blood sample, usually taken during a routine appointment. The researchers will then track your progress from your existing medical records.

Who can join this study?

The study is for people aged 60 or over with lymphoma who are starting their first or second course of chemotherapy, and who meet other specific health criteria.

How to find out more

Prasha Sasitharakumar, MHSc

prasha.sasitharakumar@sunnybrook.ca (416) 480-5000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.