A Phase 2 interventional study of Dexrazoxane and Dexrazoxane placebo in Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity and Lymphoma, sponsored by Beth Israel Deaconess Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
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:
This phase II, multicenter, randomized, double-blind, double-dummy 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.
Participants will be assigned by the study doctor to standard of care R-CHOP or standard of care pola-R-CHP therapy regimens.
R-CHOP Participants will be randomized into 1 of 2 study groups: Group A: Dexrazoxane, cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab versus Group B: Placebo, cyclophosphamide, liposomal doxorubicin, vincristine, prednisone, rituximab. Participants will have an equal chance of being placed into one of those study groups.
Pola-R-CHP participants will be randomized into 1 of 2 study groups: Group C: Dexrazoxane, cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab versus Group D: Placebo, cyclophosphamide, liposomal doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab. Participants will have an equal chance of being placed into one of those study groups.
Randomization means a participant is placed into a study group by chance. Neither a participant or the study doctor will choose or know what group a participant is placed in. This is called a "double-blind" study.
The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, electrocardiograms (ECGs), and echocardiograms (ECHO).
The U.S. Food and Drug Administration (FDA) has not approved dexrazoxane for DLBCL.
The FDA has not approved liposomal doxorubicin for DLBCL. The FDA has approved all the drugs in R-CHOP as a treatment option for DLBCL. The FDA has approved all the drugs in pola-R-CHP as a treatment option for DLBCL It is expected that about 60 people will take part in this research study. The National Cancer Institute is sponsoring this study by providing funding.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must have ONE or more of the following risk factors for HF events with anthracycline-containing chemotherapy
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Dexrazoxane · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Prednisone · Drug: Rituximab
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
Drug: Dexrazoxane placebo · Drug: Liposomal Doxorubicin · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Prednisone · Drug: Rituximab
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
Drug: Dexrazoxane · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Prednisone · Drug: Rituximab · Drug: Polatuzumab Vedotin
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
Drug: Dexrazoxane placebo · Drug: Liposomal Doxorubicin · Drug: Cyclophosphamide · Drug: Prednisone · Drug: Rituximab · Drug: Polatuzumab Vedotin
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
Drug: Dexrazoxane · Drug: Dexrazoxane placebo · Drug: Doxorubicin · Drug: Liposomal Doxorubicin · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Prednisone · Drug: Rituximab
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
Drug: Dexrazoxane placebo · Drug: Doxorubicin · Drug: Liposomal Doxorubicin · Drug: Cyclophosphamide · Drug: Prednisone · Drug: Rituximab · Drug: Polatuzumab Vedotin
Topoisomerase II Inhibitor, single-dose vial, via intravenous infusion per protocol.
Also known as: C11H16N4O4
Dexrazoxane placebo via intravenous infusion per protocol.
Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
Also known as: doxorubicin hydrochloride, C27H29NO11•HCL, ADRIAMYCIN, FI-106
Topoisomerase II Inhibitors, single-dose vial, via intravenous infusion per protocol.
Also known as: doxorubicin hydrochloride, Caelyx, Doxil, TLC-DOXO, PLD, Pegylated Liposomal Doxorubicin, TLC D-99, ATI-0918
Lymphodepleting chemotherapy, multi-dose vial, via intravenous infusion per standard of care.
Also known as: C7H15Cl2N2O2P•H2O, Cytoxan, Cyclophosphamide-OE
vinca alkaloid, single-dose vial, via intravenous infusion per standard of care.
Also known as: Vincristine Sulfate, C46H56N4O10
Glucocorticoid, tablet taken orally per standard of care.
Also known as: C21H26O5
Anti-CD20 antibody, single-use vials, via intravenous infusion per standard of care.
Also known as: Riabni, Rituxan, Ruxience, Truxima, ABP 798, IDEC-C2B8, PF-05280586
CD79b-directed antibody-drug conjugate, single-dose vial, via intravenous infusion per standard of care.
Also known as: Polatuzumab Vedotin-piiq
Left Ventricular Ejection Fraction (LVEF)
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).
Time frame: LVEF will be assessed by echocardiography 3 months after completion of front-line chemotherapy, with chemotherapy administered for up to 18 weeks.
Time to First Heart Failure (HF) Events
Time to first HF events is defined as the time from randomization to the first adjudicated heart failure event, including HF-related hospitalizations, emergency department visits, or urgent outpatient visits for worsening HF, or censoring at last follow-up, study withdrawal, based on a cause-specific hazard model.
Time frame: Up to 5 years
Time to Recurrent Heart Failure (HF) Events
Time to recurrent HF events is defined as the time from randomization to all adjudicated heart failure event, including HF-related hospitalizations, emergency department visits, or urgent outpatient visits for worsening HF, or censoring at last follow-up, study withdrawal, based on Andersen-Gill or Lin-Wei-Ying-Yang (LWYY) models.
Time frame: Up to 5 years
Changes in 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score from Baseline
This endpoint evaluates score changes in self-reported health status using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which ranges from 0 to 70, with higher scores indicating better health status. Clinically meaningful changes are defined as 5-, 10-, and 20-point thresholds.
Time frame: Health status will be assessed at baseline, at cycle 3 of chemotherapy, at 3 and 12 months post-chemotherapy, and annually through 5 years, with chemotherapy administered for up to 18 weeks.
Changes in Patient-Reported Outcomes Measurement Information System 10-Item Global Health Scale (PROMIS-10) Score from Baseline
This endpoint evaluates changes in self-reported global health status using the 10-item PROMIS Global scale (PROMIS-10), in which the first 9 items are scored 1-5 and the last item is scored 0-10, with higher scores indicating better overall physical and mental health.
Time frame: Health status will be assessed at baseline, at cycle 3 of chemotherapy, at 3 and 12 months post-chemotherapy, and annually through 5 years, with chemotherapy administered for up to 18 weeks.
Change in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)
NT-proBNP is measured in picograms per milliliter (pg/mL) using established laboratory methods. Values are collected to assess changes in neurohormonal activation.
Time frame: Biomarkers will be measured at baseline prior to chemotherapy, every 2 cycles during chemotherapy, and at 3 and 12 months post-chemotherapy to assess treatment-related changes over time, with chemotherapy administered for up to 18 weeks.
Change in High-Sensitivity Troponin
High-sensitivity troponin is measured in nanograms per liter (ng/L) using established
Time frame: Biomarkers will be measured at baseline prior to chemotherapy, every 2 cycles during chemotherapy, and at 3 and 12 months post-chemotherapy to assess treatment-related changes over time, with chemotherapy administered for up to 18 weeks.
Median Progression-Free Survival (PFS)
PFS based on Kaplan-Meier method is defined as from date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause. Participants last known to be alive and without report of progression are censored at date of last contact.
Time frame: Up to 5 years
Time to First Cardiovascular (CV) Event
Time to first CV event is defined as the time from randomization to the first adjudicated major cardiovascular event, including acute coronary syndrome, ischemic or hemorrhagic stroke, atrial fibrillation or atrial flutter, or ventricular tachycardia, with death treated as a competing risk.
Time frame: Up to 5 years
Median Overall Survival (OS)
OS based on Kaplan-Meier method is defined as the time from randomization (or registration) to death due to any cause or censored at date last known alive.
Time frame: Up to 5 years
Cause-Specific Mortality
Cause-specific mortality will be analyzed using a cause-specific proportional hazards model, with deaths from other causes treated as competing risks, to estimate the relative effect of treatment on cause-specific mortality.
Time frame: Up to 5 years
Grade 2 or Higher Adverse Event (AE) Rate
Grade 2 or higher AE rate is defined as the proportion of participants who experience grade 2 or higher AE. AE will be summarized and graded based on CTCAE 5.0.
Time frame: Adverse events will be monitored up to 12 months after completion of chemotherapy, with chemotherapy administered for up to 18 weeks.
Grade 3 or Higher Adverse Event (AE) Rate
Grade 3 or higher AE rate is defined as the proportion of participants who experience grade 3 or higher AE. AE will be summarized and graded based on CTCAE 5.0.
Time frame: Adverse events will be monitored up to 12 months after completion of chemotherapy, with chemotherapy administered for up to 18 weeks.
Plan to share: Yes — The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be shared no earlier than 1 year following the date of publication
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.
Of 210 non-industry phase 2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 96. This study's planned 48 months is below that.
Counting every sponsor, half of 264 studies reached it within 52 months; a quarter within 35 and three quarters within 85.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Dec 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexrazoxane · Doxorubicin · Vincristine · Polatuzumab vedotin
Lymphoma, Large B-Cell, Diffuse →
Beth Israel Deaconess Medical Center →