The CARDIOPROTECT Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT07654426
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cardiotoxicity
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexrazoxane — DRUG
    Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.
  • Dexrazoxane placebo — DRUG
    Dexrazoxane placebo via intravenous infusion per protocol.
  • Doxorubicin — DRUG
    Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
  • Liposomal Doxorubicin — DRUG
    Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
  • Cyclophosphamide — DRUG
    Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.
  • Vincristine — DRUG
    vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.
  • Prednisone — DRUG
    Glucocorticoid, tablet taken orally per standard of care.
  • Rituximab — DRUG
    Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.
  • Polatuzumab Vedotin — DRUG
    CD79b-directed antibody-drug conjugate, single-dose vial, via intravenous infusion per standard of care.

Study Details

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

Key Dates

Start date
Oct 2, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2035

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 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
  • 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 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
  • 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 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
  • 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 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
  • 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 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
  • 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 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

Primary Outcome Measure

Left Ventricular Ejection Fraction (LVEF) [ Time Frame: LVEF will be assessed by echocardiography 3 months after completion of front-line chemotherapy, with chemotherapy administered for up to 18 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jenica Upshaw, MD, MSc
[email protected]
(617) 667-8800

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