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Not yet taking people in United StatesPhase 2

Protecting the heart during chemotherapy for diffuse large B-cell lymphoma

Compares dexrazoxane with liposomal doxorubicin to protect hearts in adults with diffuse large B-cell lymphoma.

Key facts

Who runs it
Beth Israel Deaconess Medical Center
Where
Boston, United StatesSee the site
Trial code
Registry title
The CARDIOPROTECT Trial
Status
Not yet recruiting
Phase
Phase 2
People taking part
60 people, planned
Starts
1 Dec 2026
Expected to end
31 Dec 2035
Type of study
Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Dexrazoxane
  • Dexrazoxane placebo
  • Doxorubicin
  • Liposomal Doxorubicin
  • Cyclophosphamide
  • Vincristine
  • Prednisone
  • Rituximab
  • Polatuzumab Vedotin
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed diffuse large B-cell lymphoma who are at high risk of heart failure and plan to get R-CHOP or pola-R-CHP chemotherapy.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Diffuse large B-cell lymphoma, lymphoma that changed from a slow-growing lymphoma, or other high-grade B-cell lymphoma. Any cancer stage is allowed.
Earlier treatment
No earlier chemotherapy for this lymphoma. Steroids before the main treatment are allowed. Treatment for a different cancer is allowed.
Biomarker or test result
Not asked for. Heart risk is needed: LVEF 30-50% on the latest heart ultrasound, or LVEF 50% with a history of heart failure, or earlier anthracycline treatment for a different cancer.

Main reasons for not taking part

  • Heart failure symptoms that limit daily activity or occur at rest (NYHA Class III or IV)
  • LVEF below 30% on the most recent heart ultrasound
  • Frailty on the simplified geriatric assessment
  • Lymphoma in the central nervous system
  • Pregnancy

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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; LVEF 30-50% on most recent echocardiogram with or without HF history; LVEF 50% with a history of HF (i.e. HF with improved EF or HF with preserved EF); 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

Who cannot take part

  • 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
  • There are no contraindicated medications. Caution and monitoring are advised with medications that can cause myelosuppression
  • 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
  • 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)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study
  • Ineligible for R-CHOP or pola-R-CHP because of liver disease per institutional policies
  • 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
  • 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)
  • Presence of central nervous system involvement
  • Patients with planned dose reductions from the first cycle ie R-mini-CHOP will be excluded
  • 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

Where in United States

  • Beth Israel Deaconess Medical CenterBoston, United StatesContact: Jenica Upshaw, MD, MScNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 6 groups in the trial

  • Arm A: Dexrazoxane + Doxorubicin + RCHOPTreatment being tested

    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 daily * Day 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

    Treatment: Dexrazoxane, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Rituximab

  • Arm B: Dexrazoxane Placebo + Liposomal Doxorubicin + RCHOPPlacebo, for comparison

    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 daily * Day 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

    Treatment: Dexrazoxane placebo, Liposomal Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Rituximab

  • Arm C: Dexrazoxane + Doxorubicin + pola-R-CHPTreatment being tested

    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 daily * Day 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

    Treatment: Dexrazoxane, Doxorubicin, Cyclophosphamide, Prednisone, Rituximab, and Polatuzumab Vedotin

  • Arm D: Dexrazoxane Placebo + Liposomal Doxorubicin + pola-R-CHPPlacebo, for comparison

    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 daily * Day 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

    Treatment: Dexrazoxane placebo, Liposomal Doxorubicin, Cyclophosphamide, Prednisone, Rituximab, and Polatuzumab Vedotin

  • Arm E: Observational R-CHOPOther group

    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 questionnaires * Standard 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

    Treatment: Dexrazoxane, Dexrazoxane placebo, Doxorubicin, Liposomal Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Rituximab

  • Arm F: Observational pola-R-CHPOther group

    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 questionnaires * Standard 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

    Treatment: Dexrazoxane placebo, Doxorubicin, Liposomal Doxorubicin, Cyclophosphamide, Prednisone, Rituximab, and Polatuzumab Vedotin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Protecting the heart during chemotherapy for diffuse large B-cell lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026