Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications

Phase

N/A

Condition

Lymphoma

Treatment

Blood test for determination of CHIP

Clinical Study ID

NCT04053439

CHIP Lymphoma

Ages > 60
All Genders

Study 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

Inclusion Criteria:

Diagnosis of a lymphoma (ex: diffuse large B cell lymphoma (DLBCL), follicularlymphoma, marginal zone lymphoma, small lymphocytic lymphoma/chronic lymphocyticleukemia, Hodgkin's lymphoma, peripheral T cell lymphoma, anaplastic large celllymphoma, angioimmunoblastic lymphoma, hairy cell leukemia, Waldenstrom'smacroglobulinemia, anaplastic large cell lymphoma, small lymphocyticlymphoma/chronic lymphocytic leukemia, and mantle cell lymphoma).
Commencing first or second-line cytotoxic chemotherapy for lymphoma with or withoutrituximab [ex: cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP),cyclophosphamide, vincristine and prednisone (CVP), Fludarabine, fludarabinecyclophosphamide (FC), Bendamustine, cisplatin, cytarabine, dexamethasone (DHAP),etoposide, cytarabine, cisplatin, prednisone (ESHAP), gemcitabine, cisplatin anddexamethasone (GDP), Cladribine, Cyclophosphamide, Epirubicin, Vincristine,Prednisone (CEOP), dose-adjusted Dose-adjusted etoposide, prednisone, vincristine,cyclophosphamide, doxorubicin (DA-EPOCH)]

Exclusion

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

Study Design

Blood test for determination of CHIP

August 08, 2019

September 30, 2026

Study 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 that population of cells a survival or 'clonal' advantage for growth. The frequency of CHIP may be higher in patients with other cancers. CHIP increases with age, and has been shown to be a risk factor associated with cardiovascular disease and a tendency to the development of bone marrow cancers at a rate of 1% per year (1,2,5). CHIP is also associated with the development of bone marrow cancers that occur after chemotherapy. The investigators want to investigate whether CHIP is also a risk factor for chemotherapy-related complications like low blood counts, infections, cardiac events, hospitalizations, dose delays and dose reductions. They are also interested in determining if CHIP may explain why some patients do not recover normal blood counts after chemotherapy finishes.

The results from this study may help physicians better understand why some people have difficulty with chemotherapy (in the short and long-term) while others do not. Screening for CHIP in older patients may become a recommended standard that allows physicians to tailor anti-cancer treatment to the patient.

Connect with a study center

Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
Active - Recruiting

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