Cardio-protection and monitoring for early phase clinical trials: Recommendations from the therapeutic advances in childhood leukemia and lymphoma (TACL) consortium

BACKGROUND: Many effective anti-cancer modalities potentially induce cardiotoxicity. Pediatric patients with relapsed/refractory hematologic malignancies are often excluded from anthracycline-containing regimens based on historical data showing population-level risk of heart failure after cumulative doses of anthracyclines without considering individual patient risk variability, modernized cumulative anthracycline equivalence ratios, novel anthracycline formulations, and use of supportive cardio-protectant medications. Additionally, standard guidelines are lacking for patients with a history of prior cardiotoxicity or previous anthracycline exposure. METHODS: The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium convened a task force to review the relevant literature and create evidence-based cardiac eligibility recommendations for patients who enroll on TACL relapse clinical trials. RESULTS: Recommendations for assessment of cardiotoxicity risk, cardiac monitoring, supportive care, management of cardiac dysfunction during therapy, and considerations for clinical trial design were created. Key guidance includes: 1) excluding potential subjects from therapies with cardiotoxic risk should be based on individual risk factors and real-time cardiac function assessments rather than past cardiotoxic exposures; 2) comprehensive subject-based cardiac monitoring before, during and after therapy is essential; 3) the liberal use of cardioprotective measures is encouraged; 4) uniform and evidence-based approaches for management of cardiac dysfunction during protocol therapy are crucial; 5) correlative cardiac aims should accompany protocols with potentially cardiotoxic therapies. CONCLUSIONS: Adoption of these updated recommendations should allow more accurate and inclusive study eligibility criteria for TACL's clinical trials and inform future trial development while ultimately improving both quality and interpretability of study data, patient safety, treatment, and outcomes.

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Journal
JNCI Journal of the National Cancer Institute
Published
2026-10-19
DOI
https://doi.org/10.1093/jnci/djag393
Primary Topic
Chemotherapy-induced cardiotoxicity and mitigation
Type
article
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article

Cardio-protection and monitoring for early phase clinical trials: Recommendations from the therapeutic advances in childhood leukemia and lymphoma (TACL) consortium

Ritu Sachdeva, Bill H. Chang, Maria Luisa Sulis, Melinda Gordon Pauly et al.
JNCI Journal of the National Cancer Institute
Chemotherapy-induced cardiotoxicity and mitigation
article

Cardio-protection and monitoring for early phase clinical trials: Recommendations from the therapeutic advances in childhood leukemia and lymphoma (TACL) consortium

Ritu Sachdeva, Bill H. Chang, Maria Luisa Sulis, Melinda Gordon Pauly, Melanie Brooke Bernhardt, Susan R. Rheingold, Teresa Rushing, Deepa Bhojwani, Susan I. Colace, Paul S. Gaynon, Andrew E. Place, Todd M. Cooper, Laura B. Ramsey, Lauren Pommert, Himalee S. Sabnis, Eric S. Schafer, Alan S. Wayne, Kasey Joanne Leger, Kristine R. Crews, Colleen Annesley, Nicole Kaiser
article en

Abstract

BACKGROUND: Many effective anti-cancer modalities potentially induce cardiotoxicity. Pediatric patients with relapsed/refractory hematologic malignancies are often excluded from anthracycline-containing regimens based on historical data showing population-level risk of heart failure after cumulative doses of anthracyclines without considering individual patient risk variability, modernized cumulative anthracycline equivalence ratios, novel anthracycline formulations, and use of supportive cardio-protectant medications. Additionally, standard guidelines are lacking for patients with a history of prior cardiotoxicity or previous anthracycline exposure. METHODS: The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium convened a task force to review the relevant literature and create evidence-based cardiac eligibility recommendations for patients who enroll on TACL relapse clinical trials. RESULTS: Recommendations for assessment of cardiotoxicity risk, cardiac monitoring, supportive care, management of cardiac dysfunction during therapy, and considerations for clinical trial design were created. Key guidance includes: 1) excluding potential subjects from therapies with cardiotoxic risk should be based on individual risk factors and real-time cardiac function assessments rather than past cardiotoxic exposures; 2) comprehensive subject-based cardiac monitoring before, during and after therapy is essential; 3) the liberal use of cardioprotective measures is encouraged; 4) uniform and evidence-based approaches for management of cardiac dysfunction during protocol therapy are crucial; 5) correlative cardiac aims should accompany protocols with potentially cardiotoxic therapies. CONCLUSIONS: Adoption of these updated recommendations should allow more accurate and inclusive study eligibility criteria for TACL's clinical trials and inform future trial development while ultimately improving both quality and interpretability of study data, patient safety, treatment, and outcomes.

JNCI Journal of the National Cancer Institute
University of Southern California (US), Cincinnati Children's Hospital Medical Center (US), St. Jude Children's Research Hospital (US), Nationwide Children's Hospital (US), Children's Mercy Hospital (US), Memorial Sloan Kettering Cancer Center (US), Children's Hospital of Philadelphia (US), Children's Hospital of Los Angeles (US), Harvard University (US), Emory University (US), Oregon Health & Science University (US), Baylor College of Medicine (US), Children's Hospital Colorado (US), Seattle Children's Hospital (US), Center for Cancer and Blood Disorders (US), USC Norris Comprehensive Cancer Center (US), Children's Healthcare of Atlanta (US), Dana-Farber/Boston Children's Cancer and Blood Disorders Center (US), University of Cincinnati (US), University of Colorado Denver (US)
Openalex Percentile: Top 12%
Chemotherapy-induced cardiotoxicity and mitigation
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