Investigating the impact of clonal hematopoiesis on chemotherapy complications in lymphoma patients
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
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 |
|---|---|
| Enrollment | 188 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | rituximab, chemotherapy, cyclophosphamide, doxorubicin, Fludarabine, prednisone |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04053439 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the concept of CHIP is gaining attention, this specific investigation into its impact on chemotherapy complications in lymphoma patients is relatively novel.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.