Status:
RECRUITING
Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Queen's University
Conditions:
Lymphoma
Chemotherapeutic Toxicity
Eligibility:
All Genders
60+ years
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...
Detailed Description
'CHIP' stands for Clonal Hematopoiesis of Indeterminate Significance (1-4). Up to 20% of individuals in the general population acquire mutations in their bone marrow stem cells as they age that give t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04053439
Start Date
August 8 2019
End Date
September 1 2026
Last Update
July 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5