RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Urine samples, Heart tracing (ECG), Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, electrocardiograms (ECGs), and echocardiograms (ECHO)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The CARDIOPROTECT trial tests whether dexrazoxane is safer and works better than liposomal doxorubicin to prevent heart failure. It is for adults with certain B-cell lymphomas, a type of cancer, who plan to get R-CHOP or pola-R-CHP treatment and have heart failure risk factors. A separate observation group may be an option for people who meet the entry rules but have a reason they cannot join the main trial, or choose not to join it.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with a tissue test showing diffuse large B-cell lymphoma or another eligible B-cell lymphoma. Any stage is allowed. R-CHOP or pola-R-CHP treatment must be planned.
  • Have had no chemotherapy for this cancer. Steroids before treatment and past treatment for a different cancer are allowed.
  • Have at least one heart risk: a heart pumping measure of 30–50% on the latest heart ultrasound; a measure of 50% with past heart failure; or past use of anthracycline chemotherapy for another cancer.
  • Other past or current cancers are allowed if they will not affect the study's safety or treatment results.
  • Agree to use birth control or avoid sex that could cause pregnancy before and during the study. Men must continue for 4 months after chemotherapy. Report a possible pregnancy right away.
  • Be able to understand the study and agree to sign a consent form.
  • People with a positive hepatitis B core antibody test may join if no virus is detected and they take medicine to prevent it from returning. People with HIV may join if they agree to take compatible HIV medicines and have no uncontrolled infections linked to weak immune defenses.
  • People with changes in both the MYC and BCL2 genes, called 'double-hit' lymphoma, may join if their doctor says they cannot receive more intensive starting chemotherapy.

Who can't join

  • Heart failure that causes shortness of breath with small tasks, such as walking a short distance, or symptoms at rest.
  • A heart pumping measure below 30% on the latest heart ultrasound.
  • Being judged frail using the study's health assessment.
  • Past allergic reactions to drugs similar to those used in the study.
  • Lymphoma involving the brain or spinal cord.
  • Liver disease that makes R-CHOP or pola-R-CHP unsafe under the treatment center's rules.
  • Plans to start with lower chemotherapy doses, such as R-mini-CHOP.
  • Pregnancy. Breastfeeding must stop during treatment because the drugs may harm the baby.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA