Clonal Hematopoiesis is a Risk Factor for Chemotherapy-Related Complications
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04053439|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment|
|Lymphoma Chemotherapeutic Toxicity||Other: Blood test for determination of CHIP|
'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.
|Study Type :||Observational|
|Estimated Enrollment :||188 participants|
|Official Title:||A Single Centre Cohort Study to Determine if Clonal Hematopoieses of Indeterminate Potential (CHIP) is a Risk Factor for Chemotherapy-Related Complications in Lymphoma Patients >= 60 Receiving Cytotoxic Chemotherapy|
|Actual Study Start Date :||August 8, 2019|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2026|
Lymphoma patients >=60 receiving cytotoxic chemotherapy
Lymphoma patients >=60 receiving cytotoxic chemotherapy who have consented to DNA extraction and analysis for CHIP.
Other: Blood test for determination of CHIP
Patients will have one additional blood draw to be sent for DNA extraction and sequencing for CHIP.
- Determine if CHIP is an independent risk factor for chemotherapy-induced complications. [ Time Frame: Up to 24 weeks ]Complications during chemotherapy defined as any or all of the following: febrile neutropenia, new grades 3-4 anemia, thrombocytopenia and neutropenia immediately (day -1 or 0) preceding next cycle of chemotherapy, secondary dose reductions or dose delays due to myelosuppression or toxicity, cardiovascular toxicity (arrhythmias, congestive heart failure, symptomatic coronary disease), secondary granulocyte colony-stimulating factor (GCSF) use due to neutropenia, inability to complete all scheduled cycles due to chemotherapy related complications, dose delays that exceed 7 days.
- Emerging dysmyelopoiesis after chemotherapy [ Time Frame: Up to 12 months after completion of chemotherapy ]
The number of patients with and without CHIP who, following at 6 and 12 months post chemotherapy have:
- Hemoglobin, white blood cell (WBC) or platelet (PLT) count that does not recover to normal pre-chemotherapy levels
- Persistant macrocytosis defined as mean cell volume (MCV) > 96 fl
- Persistant anisocytosis defined as red cell distribution width (RDW) > 14.5%
- Expansion of clonal hematopoietic stem cells [ Time Frame: Up to 5 years after completion of chemotherapy ]Expansion of clonal hematopoietic stem cells over time measured using next generation sequencing of 40 myeloid genes in patients with CHIP at baseline defined by variant allele frequency (VAF) that increases by 10% of more or the emergence of new clones
- Development of therapy-related myeloid neoplasm [ Time Frame: Up to 5 years after completion of chemotherapy ]Therapy-related myeloid neoplasm defined as any of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), myeloproliferative neoplasm (MPN), MDS/MPN diagnosed by bone marrow exam
- Overall survival [ Time Frame: Up to 5 years after completion of chemotherapy ]Overall survival
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053439
|Contact: Arlene Mete||(416) 480-6100 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Rena Buckstein, MD 416-480-5847 email@example.com|
|Principal Investigator:||Rena Buckstein, MD, FRCPC||Sunnybrook Health Sciences Centre|
|Principal Investigator:||Hubert Tsui, MD||Sunnybrook Health Sciences Centre|
|Principal Investigator:||Michael Rauh, MD||Queen's University|