The CARDIOPROTECT Trial: Comparing Heart Protection in Lymphoma Treatments
Sponsor: Beth Israel Deaconess Medical Center
ClinicalTrials ID:NCT07654426
This study is testing whether the drug dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart problems in patients with diffuse large B-cell lymphoma (DLBCL) who are receiving standard chemotherapy treatments.
Patient Parameters
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Program Overview
The trial aims to find out if dexrazoxane can better protect the heart compared to liposomal doxorubicin in patients with diffuse large B-cell lymphoma (DLBCL) undergoing standard chemotherapy treatments. The study involves two main chemotherapy regimens: R-CHOP and pola-R-CHP, which include a combination of drugs used to treat DLBCL. Participants will be randomly assigned to receive either dexrazoxane or liposomal doxorubicin along with their chemotherapy regimen. The study will involve regular clinic visits, blood tests, heart tests, and questionnaires to monitor participants' health and the effects of the treatment.
Description
This study is a phase II trial conducted at multiple centers to compare the safety and effectiveness of dexrazoxane versus liposomal doxorubicin in preventing heart problems in patients with diffuse large B-cell lymphoma (DLBCL) receiving chemotherapy. Participants will be randomly assigned to one of two groups for each chemotherapy regimen (R-CHOP or pola-R-CHP). In the R-CHOP group, participants will receive either dexrazoxane or liposomal doxorubicin along with other standard drugs. In the pola-R-CHP group, participants will receive either dexrazoxane or liposomal doxorubicin with their chemotherapy drugs. Randomization means participants are placed into groups by chance, and neither the participants nor the doctors will know which group they are in. This is called a "double-blind" study. The study will include various procedures such as eligibility screening, clinic visits, blood and urine tests, and heart function tests. The FDA has not approved dexrazoxane or liposomal doxorubicin specifically for DLBCL, but the other drugs in the chemotherapy regimens are approved for this condition. About 60 people are expected to participate in this study, which is sponsored by the National Cancer Institute.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of diffuse large B-cell lymphoma or related types and plan to receive R-CHOP or pola-R-CHP treatment.
- Must not have received any prior chemotherapy for this cancer, but previous treatment for other cancers is allowed.
- Must be 18 years or older.
- Must have one or more risk factors for heart problems with chemotherapy, such as reduced heart function or previous exposure to certain cancer drugs.
- Must agree to use effective birth control during the study and for a period after treatment.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Severe heart problems that limit physical activity.
- Very low heart function on recent tests.
- Frailty as determined by a specific assessment.
- Allergic reactions to similar drugs used in the study.
- Cancer spread to the central nervous system.
- Certain genetic changes in the cancer that require different treatment.
- Ineligible for R-CHOP or pola-R-CHP due to liver disease.
- Planned dose reductions from the first cycle of treatment.
- Positive Hepatitis B core antibody without viral load control.
- HIV-positive patients without suitable treatment options or with uncontrolled infections.
- Pregnant or breastfeeding women due to potential risks to the baby.
- Eligibility for an observational arm if not eligible for the main trial or if declining participation in the randomized trial.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
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