Investigating the impact of clonal hematopoiesis on chemotherapy complications in lymphoma patients
Official title: A Single Centre Cohort Study to Determine if Clonal Hematopoieses of Indeterminate Potential (CHIP) is a Risk Factor for Chemotherapy-Related Complications in Lymphoma Patients >= 60 Receiving Cytotoxic Chemotherapy
Run by Sunnybrook Health Sciences Centre · NCT04053439 · Data updated 2026-11-12
This study is trying to see if having a certain blood condition called CHIP makes older lymphoma patients more likely to have problems like low blood counts and infections while they are getting chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | rituximab, chemotherapy, cyclophosphamide, doxorubicin, Fludarabine, prednisone |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | August 8, 2019 |
| Main results expected | January 2026 |
| Study ends | September 2026 |
| Registry record updated | July 8, 2025 |
| Trial ID | NCT04053439 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are lymphoma patients aged 60 years and older who are starting their first or second line of cytotoxic chemotherapy.
✕Probably not a fit
Patients who are younger than 60 or those who do not have a diagnosis of lymphoma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines the role of Clonal Hematopoiesis of Indeterminate Significance (CHIP) in patients aged 60 and older who are diagnosed with lymphoma and undergoing chemotherapy. The research aims to determine if the presence of CHIP increases the risk of complications such as low blood counts, infections, and hospitalizations during and after chemotherapy treatment. By analyzing blood samples, the study seeks to identify the relationship between CHIP and chemotherapy-related adverse effects, potentially leading to tailored treatment strategies for older patients. The findings may enhance understanding of why some patients experience more severe complications than others.
Why it matters
Potential benefit: If successful, this study could lead to improved management of chemotherapy in older lymphoma patients by identifying those at higher risk for complications.
How similar studies have gone: While the concept of CHIP is gaining attention, this specific investigation into its impact on chemotherapy complications in lymphoma patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of a lymphoma (ex: diffuse large B cell lymphoma (DLBCL), follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia, Hodgkin's lymphoma, peripheral T cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic lymphoma, hairy cell leukemia, Waldenstrom's macroglobulinemia, anaplastic large cell lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia, and mantle cell lymphoma). * Commencing first or second-line cytotoxic chemotherapy for lymphoma with or without rituximab \[ex: cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), cyclophosphamide, vincristine and prednisone (CVP), Fludarabine, fludarabine cyclophosphamide (FC), Bendamustine, cisplatin, cytarabine, dexamethasone (DHAP), etoposide, cytarabine, cisplatin, prednisone (ESHAP), gemcitabine, cisplatin and dexamethasone (GDP), Cladribine, Cyclophosphamide, Epirubicin, Vincristine, Prednisone (CEOP), dose-adjusted Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (DA-EPOCH)\] Exclusion Criteria: * Pre-existing diagnosis of myeloid neoplasm * Circulating lymphocyte count \> 10 x 109/L * Significant uncontrolled renal or hepatic impairment \[\>1.5 x upper limit of normal (ULN) bilirubin, \>1.5 x ULN Alanine aminotransferase (ALT), \>1.5 x ULN creatinine\] * HIV * Active infection
Where it's running
-
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Rena Buckstein, MD, FRCPC — Sunnybrook Health Sciences Centre
- Study coordinator: Prasha Sasitharakumar, MHSc
- Email: prasha.sasitharakumar@sunnybrook.ca
- Phone: (416) 480-5000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.