NCT04053439 Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications
| NCT ID | NCT04053439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 188 participants |
| Start Date | 2019-08-08 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 188 participants in total. It began in 2019-08-08 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
'CHIP' stands for Clonal Hematopoiesis of Indeterminate Significance, which are mutations in bone marrow stem cells that give that population of cells a survival or 'clonal' advantage for growth. This study investigates whether CHIP in lymphoma patients aged 60 years and older is a risk factor for chemotherapy-related complications like low blood counts, infections, cardiac events, hospitalizations, dose delays and dose reductions, and failure to recover normal blood counts after chemotherapy finishes.
Eligibility 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
Contact & Investigator
Rena Buckstein, MD, FRCPC
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT04053439 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04053439 currently recruiting?
Yes, NCT04053439 is actively recruiting participants. Contact the research team at prasha.sasitharakumar@sunnybrook.ca for enrollment information.
Where is the NCT04053439 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04053439 clinical trial?
NCT04053439 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Rena Buckstein, MD, FRCPC at Sunnybrook Health Sciences Centre. The trial plans to enroll 188 participants.