Age-related clonal hematopoiesis associated with adverse outcomes.
Siddhartha Jaiswal, Pierre Fontanillas, Jason Flannick...
https://pubmed.ncbi.nlm.nih.gov/25426837Actively Recruiting
Age: 60Years +
All Genders
ID04053439
A Single Centre Cohort Study to Determine if Clonal Hematopoiesis of Indeterminate Potential (CHIP) Is a Risk Factor for Chemotherapy-Related Complications in Lymphoma Patients Aged 60 and Older Receiving Cytotoxic Chemotherapy
Led by Sunnybrook Health Sciences Centre · Updated on 2025-07-08
188
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether Clonal Hematopoiesis of Indeterminate Significance (CHIP), which involves mutations in bone marrow stem cells that give certain cells a growth advantage, is a risk factor for chemotherapy-related complications in lymphoma patients aged 60 years and older. CHIP is known to increase with age and is linked to cardiovascular disease and bone marrow cancers. This study aims to understand if CHIP contributes to problems like low blood counts, infections, heart events, hospitalizations, chemotherapy dose delays or reductions, and poor blood count recovery after chemotherapy. Participants are lymphoma patients aged 60 and above who are starting their first or second line of cytotoxic chemotherapy, with or without rituximab. The study involves an additional blood test to analyze DNA for the presence of CHIP mutations. This observational study follows patients to see if CHIP is connected to chemotherapy complications and changes in blood cell development over time. During the study, participants will be monitored for up to 24 weeks to determine if CHIP predicts chemotherapy complications and up to 12 months to observe emerging blood cell abnormalities after treatment. Secondary outcomes like the growth of clonal stem cells, development of therapy-related bone marrow cancers, and overall survival will be tracked for up to 5 years. Researchers collect medical data and blood samples to assess these outcomes and better understand how CHIP affects treatment response and patient health.
CONDITIONS
Brief Title
Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of lymphoma, such as diffuse large B cell lymphoma, 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, or mantle cell lymphoma
- Starting first or second-line cytotoxic chemotherapy for lymphoma, with or without rituximab
- Age 60 years or older
You will not qualify if you...
- Pre-existing diagnosis of myeloid neoplasm
- Circulating lymphocyte count greater than 10 x 10^9/L
- Significant uncontrolled kidney or liver problems (bilirubin, ALT, or creatinine over 1.5 times the upper limit of normal)
- HIV infection
- Active infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 24 weeks
Participants undergo blood tests and clinical assessments to investigate the presence of clonal hematopoiesis and monitor chemotherapy-related complications such as low blood counts, infections, cardiac events, hospitalizations, dose delays, and dose reductions.
Visits aligned with chemotherapy treatment schedule
Long-term Monitoring
Duration - Up to 5 years after completion of chemotherapy
Participants are observed to assess recovery of blood counts, expansion of clonal hematopoietic stem cells, development of therapy-related myeloid neoplasm, and overall survival after chemotherapy completion.
Periodic visits over several years
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
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Research Team
P
Prasha Sasitharakumar, MHSc
A
Anne Parmentier
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Clonal hematopoiesis and blood-cancer risk inferred from blood DNA sequence.
Giulio Genovese, Anna K Kähler, Robert E Handsaker...
https://pubmed.ncbi.nlm.nih.gov/25426838Leukemia-associated somatic mutations drive distinct patterns of age-related clonal hemopoiesis.
Thomas McKerrell, Naomi Park, Thaidy Moreno...
https://pubmed.ncbi.nlm.nih.gov/25732814Age-related mutations associated with clonal hematopoietic expansion and malignancies.
Mingchao Xie, Charles Lu, Jiayin Wang...
https://pubmed.ncbi.nlm.nih.gov/25326804Clonal hematopoiesis of indeterminate potential and its distinction from myelodysplastic syndromes.
David P Steensma, Rafael Bejar, Siddhartha Jaiswal...
https://pubmed.ncbi.nlm.nih.gov/25931582