The CARDIOPROTECT Trial

A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial

This trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments.

The names of the study drugs involved in this study are:

• Dexrazoxane (a type of Topoisomerase II Inhibitor)
• Liposomal Doxorubicin (a type of Topoisomerase II Inhibitor)
• Standard of care R-CHOP treatment regimen (Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab)
• Standard of care pola-R-CHP treatment regimen: Cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma; Cardiotoxicity; Diffuse Large B-cell Lymphoma (DLBCL)
• Intervention / Treatment: Drug: Dexrazoxane; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: Dexrazoxane placebo; Drug: Liposomal Doxorubicin; Drug: Polatuzumab Vedotin

Detailed Description

This phase II, multicenter, randomized, double-blind, double-dummy trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments.

Participants will be assigned by the study doctor to standard of care R-CHOP or standard of care pola-R-CHP therapy regimens.

R-CHOP Participants will be randomized into 1 of 2 study groups: Group A: Dexrazoxane, cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab versus Group B: Placebo, cyclophosphamide, liposomal doxorubicin, vincristine, prednisone, rituximab. Participants will have an equal chance of being placed into one of those study groups.

Pola-R-CHP participants will be randomized into 1 of 2 study groups: Group C: Dexrazoxane, cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab versus Group D: Placebo, cyclophosphamide, liposomal doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab. Participants will have an equal chance of being placed into one of those study groups.

Randomization means a participant is placed into a study group by chance. Neither a participant or the study doctor will choose or know what group a participant is placed in. This is called a "double-blind" study.

The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, electrocardiograms (ECGs), and echocardiograms (ECHO).

The U.S. Food and Drug Administration (FDA) has not approved dexrazoxane for DLBCL.

The FDA has not approved liposomal doxorubicin for DLBCL. The FDA has approved all the drugs in R-CHOP as a treatment option for DLBCL. The FDA has approved all the drugs in pola-R-CHP as a treatment option for DLBCL It is expected that about 60 people will take part in this research study. The National Cancer Institute is sponsoring this study by providing funding.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jenica Upshaw, MD, MSc; Phone Number: (617) 667-8800; Email: jupshaw@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
      • Contact: Jenica Upshaw, MD, MSc; Phone Number: (617) 667-8800; Email: jupshaw@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have histologically confirmed diffuse large B-cell lymphoma, histologically transformed large B cell lymphoma from a prior indolent lymphoma, or other high-grade B-cell lymphoma for which R-CHOP or pola-R-CHP are planned. Any cancer stage is permitted.
• Participants must not have received any prior chemotherapy for this malignancy. Pre-phase steroids are allowed. Prior treatment for a different malignancy is allowed, including prior treatment for indolent lymphoma.
• Age ≥18 years. Diffuse large B cell lymphoma is rare in participants <18 years of age. The prevalence of HF prior to chemotherapy is also exceedingly rare in participants <18 years of age; therefore, participants <18 years of age are excluded from this study.

• Participants must have ONE or more of the following risk factors for HF events with anthracycline-containing chemotherapy

  1. LVEF 30-50% on most recent echocardiogram with or without HF history
  2. LVEF 50% with a history of HF (i.e. HF with improved EF or HF with preserved EF).
  3. History of anthracycline exposure for different malignancy.
• Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Because dexrazoxane as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• New York Heart Association (NYHA) Class III or IV exertional dyspnea. The symptoms should be attributed to HF and not due to lymphoma, anemia, arthritis or other causes per the assessment of the treating clinician or study investigator. NYHA Class III defined as: "Marked limitations with less than ordinary activity such as walking short distances or climbing a few stairs" and NYHA Class IV defined as: "Inability to carry out any activity without discomfort. Symptoms are present at rest and if any physical activity is undertaken the symptoms are increased." (see Appendix A for NYHA Classification).
• LVEF <30% on most recent echocardiogram. Patients with prior LVEF <30% with improvement to >30% on most recent echocardiogram are eligible.
• Meeting criteria for frailty according to the simplified geriatric assessment (see Appendix A for the simplified geriatric assessment criteria).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
• Presence of central nervous system involvement
• Presence of concurrent genetic rearrangements of the MYC and BCL2 genes, so called "double-hit" large-cell lymphoma who are not deemed eligible for intensified induction chemotherapy such as dose adjusted EPOCH-R by their treating physician can be enrolled
• Ineligible for R-CHOP or pola-R-CHP because of liver disease per institutional policies
• Patients with planned dose reductions from the first cycle ie R-mini-CHOP will be excluded
• There are no contraindicated medications. Caution and monitoring are advised with medications that can cause myelosuppression.
• Patients with positive Hepatitis B core antibody can be enrolled if they have negative viral load and can be maintained on antiviral prophylaxis
• Patients with HIV can be enrolled if they have anti-retroviral therapy options without drug-drug interactions with the cancer treatment, agree to take anti-retroviral therapy and do not have uncontrolled opportunistic infections.
• Pregnant women are excluded from this study because dexrazoxane and liposomal doxorubicin are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dexrazoxane and liposomal doxorubicin, breastfeeding should be discontinued if the mother is treated with dexrazoxane and liposomal doxorubicin. These potential risks may also apply to other agents used in this study.
• Eligibility for observational arm of the study. The above inclusion and exclusion criteria are for the randomized trial. Patients who meet the inclusion criteria but have one or more exclusion criterion are eligible to participate in the observational arm of the study. In addition, patients who meet all eligibility criteria for the randomized trial but decline participation in the randomized trial are also eligible to participate in the observational arm of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Dexrazoxane + Doxorubicin + RCHOP; Participants will be randomized in 1:1 ratio and stratified by cancer stage and enrolling site to this group and will complete: Baseline visit; Cycle 1 through End of Treatment (21 day cycles):Day 1: predetermined dose of Dexrazoxane 1x dailyDay 1: predetermined dose of Doxorubicin 1x daily; Standard of care R-CHOP per protocol; 3 and 12 month follow up post-standard of care treatment completion; Long term follow up: annually from year 2 - 5	Drug: Dexrazoxane; Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.; Other Names: C11H16N4O4; Drug: Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, C27H29NO11•HCL, ADRIAMYCIN, FI-106; Drug: Cyclophosphamide; Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.; Other Names: C7H15Cl2N2O2P•H2O, Cytoxan, Cyclophosphamide-OE; Drug: Vincristine; vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.; Other Names: Vincristine Sulfate, C46H56N4O10; Drug: Prednisone; Glucocorticoid, tablet taken orally per standard of care.; Other Names: C21H26O5; Drug: Rituximab; Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.; Other Names: Riabni, Rituxan, Ruxience, Truxima, ABP 798, IDEC-C2B8, PF-05280586
Placebo Comparator: Arm B: Dexrazoxane Placebo + Liposomal Doxorubicin + RCHOP; Participants will be randomized in 1:1 ratio and stratified by cancer stage and enrolling site to this group and will complete: Baseline visit; Cycle 1 through End of Treatment (21 day cycles):Day 1: predetermined dose of Dexrazoxane placebo 1x dailyDay 1: predetermined dose of Liposomal Doxorubicin 1x daily; Standard of care R-CHOP per protocol; 3 and 12 month follow up post-standard of care treatment completion; Long term follow up: annually from year 2 - 5	Drug: Cyclophosphamide; Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.; Other Names: C7H15Cl2N2O2P•H2O, Cytoxan, Cyclophosphamide-OE; Drug: Vincristine; vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.; Other Names: Vincristine Sulfate, C46H56N4O10; Drug: Prednisone; Glucocorticoid, tablet taken orally per standard of care.; Other Names: C21H26O5; Drug: Rituximab; Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.; Other Names: Riabni, Rituxan, Ruxience, Truxima, ABP 798, IDEC-C2B8, PF-05280586; Drug: Dexrazoxane placebo; Dexrazoxane placebo via intravenous infusion per protocol.; Drug: Liposomal Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, Caelyx, Doxil, TLC-DOXO, PLD, Pegylated Liposomal Doxorubicin, TLC D-99, ATI-0918
Experimental: Arm C: Dexrazoxane + Doxorubicin + pola-R-CHP; Participants will be randomized in 1:1 ratio and stratified by cancer stage and enrolling site to this group and will complete: Baseline visit; Cycle 1 through End of Treatment (21 day cycles):Day 1: predetermined dose of Dexrazoxane 1x dailyDay 1: predetermined dose of Doxorubicin 1x daily; Standard of care pola-R-CHP per protocol; 3 and 12 month follow up post-standard of care treatment completion; Long term follow up: annually from year 2 - 5	Drug: Dexrazoxane; Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.; Other Names: C11H16N4O4; Drug: Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, C27H29NO11•HCL, ADRIAMYCIN, FI-106; Drug: Cyclophosphamide; Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.; Other Names: C7H15Cl2N2O2P•H2O, Cytoxan, Cyclophosphamide-OE; Drug: Prednisone; Glucocorticoid, tablet taken orally per standard of care.; Other Names: C21H26O5; Drug: Rituximab; Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.; Other Names: Riabni, Rituxan, Ruxience, Truxima, ABP 798, IDEC-C2B8, PF-05280586; Drug: Polatuzumab Vedotin; CD79b-directed antibody-drug conjugate, single-dose vial, via intravenous infusion per standard of care.; Other Names: Polatuzumab Vedotin-piiq
Placebo Comparator: Arm D: Dexrazoxane Placebo + Liposomal Doxorubicin + pola-R-CHP; Participants will be randomized in 1:1 ratio and stratified by cancer stage and enrolling site to this group and will complete: Baseline visit; Cycle 1 through End of Treatment (21 day cycles):Day 1: predetermined dose of Dexrazoxane placebo 1x dailyDay 1: predetermined dose of Liposomal Doxorubicin 1x daily; Standard of care pola-R-CHP per protocol; 3 and 12 month follow up post-standard of care treatment completion; Long term follow up: annually from year 2 - 5	Drug: Cyclophosphamide; Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.; Other Names: C7H15Cl2N2O2P•H2O, Cytoxan, Cyclophosphamide-OE; Drug: Prednisone; Glucocorticoid, tablet taken orally per standard of care.; Other Names: C21H26O5; Drug: Rituximab; Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.; Other Names: Riabni, Rituxan, Ruxience, Truxima, ABP 798, IDEC-C2B8, PF-05280586; Drug: Dexrazoxane placebo; Dexrazoxane placebo via intravenous infusion per protocol.; Drug: Liposomal Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, Caelyx, Doxil, TLC-DOXO, PLD, Pegylated Liposomal Doxorubicin, TLC D-99, ATI-0918; Drug: Polatuzumab Vedotin; CD79b-directed antibody-drug conjugate, single-dose vial, via intravenous infusion per standard of care.; Other Names: Polatuzumab Vedotin-piiq
Other: Arm E: Observational R-CHOP; Participants meeting inclusion but not all exclusion criteria, or who decline randomization, may enroll in an observational cohort for data and biospecimen collection and will complete the following: Baseline visit with assessments and questionnaires; Cycle 1 through End of Treatment (21 day cycles):Day 1: assessments and questionnairesStandard of care R-CHOP; 3 and 12 month follow up post-treatment completion; Long term follow up: annually from year 2 - 5, in-person or virtually	Drug: Dexrazoxane; Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.; Other Names: C11H16N4O4; Drug: Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, C27H29NO11•HCL, ADRIAMYCIN, FI-106; Drug: Cyclophosphamide; Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.; Other Names: C7H15Cl2N2O2P•H2O, Cytoxan, Cyclophosphamide-OE; Drug: Vincristine; vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.; Other Names: Vincristine Sulfate, C46H56N4O10; Drug: Prednisone; Glucocorticoid, tablet taken orally per standard of care.; Other Names: C21H26O5; Drug: Rituximab; Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.; Other Names: Riabni, Rituxan, Ruxience, Truxima, ABP 798, IDEC-C2B8, PF-05280586; Drug: Dexrazoxane placebo; Dexrazoxane placebo via intravenous infusion per protocol.; Drug: Liposomal Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, Caelyx, Doxil, TLC-DOXO, PLD, Pegylated Liposomal Doxorubicin, TLC D-99, ATI-0918
Other: Arm F: Observational pola-R-CHP; Participants meeting inclusion but not all exclusion criteria, or who decline randomization, may enroll in an observational cohort for data and biospecimen collection and will complete the following: Baseline visit with assessments and questionnaires; Cycle 1 through End of Treatment (21 day cycles):Day 1: assessments and questionnairesStandard of care pola-R-CHP; 3 and 12 month follow up post-treatment completion; Long term follow up: annually from year 2 - 5, in-person or virtually	Drug: Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, C27H29NO11•HCL, ADRIAMYCIN, FI-106; Drug: Cyclophosphamide; Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.; Other Names: C7H15Cl2N2O2P•H2O, Cytoxan, Cyclophosphamide-OE; Drug: Prednisone; Glucocorticoid, tablet taken orally per standard of care.; Other Names: C21H26O5; Drug: Rituximab; Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.; Other Names: Riabni, Rituxan, Ruxience, Truxima, ABP 798, IDEC-C2B8, PF-05280586; Drug: Dexrazoxane placebo; Dexrazoxane placebo via intravenous infusion per protocol.; Drug: Liposomal Doxorubicin; Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.; Other Names: doxorubicin hydrochloride, Caelyx, Doxil, TLC-DOXO, PLD, Pegylated Liposomal Doxorubicin, TLC D-99, ATI-0918; Drug: Polatuzumab Vedotin; CD79b-directed antibody-drug conjugate, single-dose vial, via intravenous infusion per standard of care.; Other Names: Polatuzumab Vedotin-piiq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Ejection Fraction (LVEF)	LVEF represents the proportion of blood ejected from the left ventricle during each heartbeat and is calculated as LVEF=(ECV-ESV)/EDV, where EDV is the end-diastolic volume (the volume of blood in the ventricle at the end of filling) and ESV is the end-systolic volume (the volume of blood remaining in the ventricle after contraction).	LVEF will be assessed by echocardiography 3 months after completion of front-line chemotherapy, with chemotherapy administered for up to 18 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Heart Failure (HF) Events	Time to first HF events is defined as the time from randomization to the first adjudicated heart failure event, including HF-related hospitalizations, emergency department visits, or urgent outpatient visits for worsening HF, or censoring at last follow-up, study withdrawal, based on a cause-specific hazard model.	Up to 5 years
Time to Recurrent Heart Failure (HF) Events	Time to recurrent HF events is defined as the time from randomization to all adjudicated heart failure event, including HF-related hospitalizations, emergency department visits, or urgent outpatient visits for worsening HF, or censoring at last follow-up, study withdrawal, based on Andersen-Gill or Lin-Wei-Ying-Yang (LWYY) models.	Up to 5 years
Changes in 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score from Baseline	This endpoint evaluates score changes in self-reported health status using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which ranges from 0 to 70, with higher scores indicating better health status. Clinically meaningful changes are defined as 5-, 10-, and 20-point thresholds.	Health status will be assessed at baseline, at cycle 3 of chemotherapy, at 3 and 12 months post-chemotherapy, and annually through 5 years, with chemotherapy administered for up to 18 weeks.
Changes in Patient-Reported Outcomes Measurement Information System 10-Item Global Health Scale (PROMIS-10) Score from Baseline	This endpoint evaluates changes in self-reported global health status using the 10-item PROMIS Global scale (PROMIS-10), in which the first 9 items are scored 1-5 and the last item is scored 0-10, with higher scores indicating better overall physical and mental health.	Health status will be assessed at baseline, at cycle 3 of chemotherapy, at 3 and 12 months post-chemotherapy, and annually through 5 years, with chemotherapy administered for up to 18 weeks.
Change in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)	NT-proBNP is measured in picograms per milliliter (pg/mL) using established laboratory methods. Values are collected to assess changes in neurohormonal activation.	Biomarkers will be measured at baseline prior to chemotherapy, every 2 cycles during chemotherapy, and at 3 and 12 months post-chemotherapy to assess treatment-related changes over time, with chemotherapy administered for up to 18 weeks.
Change in High-Sensitivity Troponin	High-sensitivity troponin is measured in nanograms per liter (ng/L) using established	Biomarkers will be measured at baseline prior to chemotherapy, every 2 cycles during chemotherapy, and at 3 and 12 months post-chemotherapy to assess treatment-related changes over time, with chemotherapy administered for up to 18 weeks.
Median Progression-Free Survival (PFS)	PFS based on Kaplan-Meier method is defined as from date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause. Participants last known to be alive and without report of progression are censored at date of last contact.	Up to 5 years
Time to First Cardiovascular (CV) Event	Time to first CV event is defined as the time from randomization to the first adjudicated major cardiovascular event, including acute coronary syndrome, ischemic or hemorrhagic stroke, atrial fibrillation or atrial flutter, or ventricular tachycardia, with death treated as a competing risk.	Up to 5 years
Median Overall Survival (OS)	OS based on Kaplan-Meier method is defined as the time from randomization (or registration) to death due to any cause or censored at date last known alive.	Up to 5 years
Cause-Specific Mortality	Cause-specific mortality will be analyzed using a cause-specific proportional hazards model, with deaths from other causes treated as competing risks, to estimate the relative effect of treatment on cause-specific mortality.	Up to 5 years
Grade 2 or Higher Adverse Event (AE) Rate	Grade 2 or higher AE rate is defined as the proportion of participants who experience grade 2 or higher AE. AE will be summarized and graded based on CTCAE 5.0.	Adverse events will be monitored up to 12 months after completion of chemotherapy, with chemotherapy administered for up to 18 weeks.
Grade 3 or Higher Adverse Event (AE) Rate	Grade 3 or higher AE rate is defined as the proportion of participants who experience grade 3 or higher AE. AE will be summarized and graded based on CTCAE 5.0.	Adverse events will be monitored up to 12 months after completion of chemotherapy, with chemotherapy administered for up to 18 weeks.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Jenica Upshaw, MD, MSc, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 2, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Lymphoma; Cardiotoxicity; Stage B Heart Failure; Stage C Heart Failure; Diffuse Large B-cell Lymphoma (DLBCL); High Risk for Heart Failure Events; Left ventricular ejection fraction (LVEF) decline
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms; Heart Diseases; Immune System Diseases; Neoplasms by Histologic Type; Chemically-Induced Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Cardiotoxicity; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Indoles; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Aminoglycosides; Antibodies, Monoclonal, Murine-Derived; Daunorubicin; Piperazines; Razoxane; Diketopiperazines; Rituximab; Prednisone; Cyclophosphamide; Doxorubicin; Vincristine; Dexrazoxane; polatuzumab vedotin; liposomal doxorubicin; 1-dodecylpyridoxal
• Other Study ID Numbers: 25-814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No