NCT07654426
The CARDIOPROTECT Trial
Recruiting
PHASE2Ages 18+InterventionalTreatmentBeth Israel Deaconess Medical CenterInvestigator-initiated
~60 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:DexrazoxaneDexrazoxane placeboDoxorubicinLiposomal DoxorubicinCyclophosphamideVincristine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Left Ventricular Ejection Fraction (LVEF)
Measured over LVEF will be assessed by echocardiography 3 months after completion of front-line chemotherapy, with chemotherapy administered for up to 18 weeks.
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Jenica Upshaw, MD, MSc · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
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.
What this trial measures
- Left Ventricular Ejection Fraction (LVEF)LVEF will be assessed by echocardiography 3 months after completion of front-line chemotherapy, with chemotherapy administered for up to 18 weeks.
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).