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Search / Trial NCT04053439

Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Aug 9, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Clonal Hematopoiesis Of Indeterminate Significance Chemotherapy Lymphoma Chemotherapy Complications

ClinConnect Summary

This clinical trial is studying how a specific condition called Clonal Hematopoiesis of Indeterminate Significance (CHIP) might affect older patients with lymphoma who are receiving chemotherapy. CHIP refers to changes in blood stem cells that can give some cells an advantage to grow more than others. Researchers want to find out if having CHIP increases the risk of complications from chemotherapy, such as low blood counts, infections, heart problems, and issues with hospital stays or medication adjustments.

To participate in this trial, patients must be 60 years or older and diagnosed with lymphoma. They should be starting their first or second round of chemotherapy. Some common types of lymphoma included are diffuse large B cell lymphoma and Hodgkin's lymphoma. Participants will be closely monitored throughout their treatment to see how CHIP may influence their recovery and any side effects they experience. This study is currently looking for volunteers, so if you or someone you know meets the eligibility criteria, it might be a chance to contribute to important research.

Gender

ALL

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

About Sunnybrook Health Sciences Centre

Sunnybrook Health Sciences Centre is a leading academic health science organization located in Toronto, Canada, renowned for its commitment to advancing patient care through innovative research and education. As a prominent clinical trial sponsor, Sunnybrook integrates cutting-edge medical research with clinical practice, focusing on a wide range of health disciplines, including cancer care, trauma, and cardiovascular health. The center collaborates with various stakeholders, including academic institutions, healthcare providers, and industry partners, to facilitate the development of novel therapies and improve health outcomes. With a robust infrastructure and a dedicated team of researchers and clinicians, Sunnybrook plays a pivotal role in translating scientific advancements into tangible benefits for patients.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Rena Buckstein, MD, FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Hubert Tsui, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Michael Rauh, MD

Principal Investigator

Queen's University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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