Health Trials

About this 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dexrazoxane
  • Dexrazoxane placebo
  • Doxorubicin
  • Liposomal Doxorubicin
  • Cyclophosphamide
  • Vincristine
  • Prednisone
  • Rituximab
  • Polatuzumab Vedotin

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

1
Beth Israel Deaconess Medical Center02215, BostonMassachusetts, United States

Sponsors and collaborators

Beth Israel Deaconess Medical Center

Lead sponsor

Source ClinicalTrials.gov