Dexrazoxane for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether dexrazoxane, a heart-protective drug, is safer and more effective than liposomal doxorubicin in preventing heart failure in individuals with diffuse large B-cell lymphoma, a type of blood cancer, who are undergoing chemotherapy. Participants will receive different combinations of these drugs alongside standard cancer treatment. The trial seeks individuals diagnosed with this lymphoma who have not yet started chemotherapy. Participants should have a history of heart problems or certain risk factors for heart failure. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that dexrazoxane can protect the heart from damage caused by doxorubicin, a common cancer drug. However, patients taking dexrazoxane experienced an increased rate of secondary brain tumors. This suggests that while dexrazoxane can enhance heart safety, it may pose other risks.
Liposomal doxorubicin, a version of the drug designed to be gentler on the heart than regular doxorubicin, has been shown in research to be generally safe and well-tolerated in the R-CHOP treatment plan.
Pola-R-CHP, which includes polatuzumab vedotin, has been studied in real-world settings. It is generally safe, though some patients experienced nerve damage and serious infections. Despite these issues, the treatment has proven effective for many patients with DLBCL.
Overall, these treatments present some safety concerns but are generally considered well-tolerated. Prospective trial participants should carefully weigh both the potential benefits and risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Dexrazoxane in the treatment of lymphoma because it offers a unique protective mechanism for the heart, which is crucial when using chemotherapy drugs like Doxorubicin. Unlike standard treatments, which can harm cardiac health, Dexrazoxane acts as a cardioprotective agent, potentially reducing the risk of heart damage without compromising the effectiveness of cancer treatment. This dual action of fighting cancer while safeguarding the heart makes it a promising addition to existing chemotherapy regimens.
What evidence suggests that this trial's treatments could be effective for preventing heart failure in diffuse large B-cell lymphoma?
Research has shown that using dexrazoxane with doxorubicin and R-CHOP, which participants in Arm A of this trial may receive, can help protect the heart during lymphoma treatment. This protection is crucial because doxorubicin, a potent cancer drug, can sometimes damage the heart. Dexrazoxane has proven effective in preventing this damage without diminishing the treatment's cancer-fighting ability. Meanwhile, participants in Arm C will receive dexrazoxane with doxorubicin and pola-R-CHP. Studies indicate a high success rate for pola-R-CHP, with up to 92% of patients responding well and 80% showing no signs of cancer. These findings suggest that both treatment combinations hold promise for effectively managing lymphoma while reducing heart-related side effects.23456
Who Is on the Research Team?
Jenica Upshaw, MD, MSc
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with diffuse large B-cell lymphoma or similar high-grade lymphomas who are about to start R-CHOP or pola-R-CHP chemo and have certain heart risk factors. Participants must not have had prior chemo for this cancer, must use contraception, and cannot join if pregnant, frail, or allergic to study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dexrazoxane or Liposomal Doxorubicin in combination with standard of care R-CHOP or pola-R-CHP regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of heart function and adverse events
Long-term Follow-up
Participants are monitored annually for heart failure events and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Dexrazoxane
- Doxorubicin
- Liposomal Doxorubicin
- Polatuzumab Vedotin
- Prednisone
- Rituximab
- Vincristine
Trial Overview
The study compares dexrazoxane versus liposomal doxorubicin to see which better prevents heart problems in people getting standard lymphoma treatments (R-CHOP or pola-R-CHP). Patients are randomly assigned to receive one of these options along with their usual chemotherapy regimen.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo 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
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
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
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
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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Citations
Long-term outcomes of R-CEOP show curative potential in ...
Overall, 27 out of 70 patients (39%) in the R-CEOP group, compared with 49 out of 140 patients (33%) in R-CHOP group, died due to lymphoma or treatment toxicity ...
Nonpegylated Liposomal Doxorubicin as a Component of ...
Doxorubicin is an anthracycline and regarded as the most effective single agent in the treatment of non-Hodgkin lymphoma (NHL).1 It is part of the R-CHOP ( ...
Study Details | NCT06220032 | Prevention of Anthracycline ...
The secondary endpoint will be the percentage of patients with complete metabolic remission (CMR) after R-CHOP chemotherapy, to reassure that dexrazoxane does ...
Prevention of Anthracycline-Induced Cardiac Dysfunction With ...
ANTICIPATE aims to evaluate if dexrazoxane can prevent AICD in DLBCL patients and identify those at highest risk of AICD. Of all patients ...
Incidence and risk-factors of CHOP/R-CHOP-related...
a recent meta-analysis showed that dexrazoxane had no effect on progression-free and overall survival in solid tumours.
Upfront dexrazoxane for the reduction of anthracycline ... - PMC
Dexrazoxane protects against the cardiotoxic effects of anthracyclines, CHOP Doxorubicin, increased rate of secondary brain tumors in the dexrazoxane arm. CHOP ...
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