Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04053439

Conditions

Lymphoma

Chemotherapeutic Toxicity

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Blood test for determination of CHIP

Study Details

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.

Conditions

Lymphoma

Chemotherapeutic Toxicity

Study ID

NCT04053439

Start date

Aug 8, 2019

Status verified date

Jun, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

188 participants

Anticipated

Interventions and Outcome Measures

Arms

Lymphoma patients >=60 receiving cytotoxic chemotherapy

Lymphoma patients >=60 receiving cytotoxic chemotherapy who have consented to DNA extraction and analysis for CHIP.

Interventions

Blood test for determination of CHIP

Patients will have one additional blood draw to be sent for DNA extraction and sequencing for CHIP.

Primary outcome measure

  • Determine if CHIP is an independent risk factor for chemotherapy-induced complications. [ Time Frame: Up to 24 weeks ]
  • Emerging dysmyelopoiesis after chemotherapy [ Time Frame: Up to 12 months after completion of chemotherapy ]

Central Contacts and Locations

Central contacts

Prasha Sasitharakumar, MHSc

(416) 480-5000prasha.sasitharakumar@sunnybrook.ca

Anne Parmentier

416 480 5000anne.parmentier@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Rena Buckstein, MD

416-480-5847rena.buckstein@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jul 8, 2025

Last verified

Jun, 2025

Keywords

  • Clonal Hematopoiesis of Indeterminate Significance
  • Chemotherapy
  • Lymphoma
  • Chemotherapy complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-07-08.