Dexrazoxane for Blood Cancer Side Effects

Overseen By Maro Ohanian

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active heart disease, Pregnant, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dexrazoxane hydrochloride can prevent heart problems caused by chemotherapy in individuals with certain blood cancers, such as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). It targets those undergoing chemotherapy who may be concerned about potential heart side effects. The trial aims to determine if this medication can protect the heart during cancer treatment. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that dexrazoxane hydrochloride is likely to be safe for humans?

Research has shown that dexrazoxane hydrochloride often protects the heart during chemotherapy and has a strong track record for this purpose. However, some studies found that it can lower blood cell counts, including white blood cells and platelets. This reduction can affect the body's ability to fight infections or stop bleeding.

Additionally, dexrazoxane might increase the risk of certain cancers, such as acute myeloid leukemia and myelodysplastic syndrome, which are rare but serious conditions.

Overall, while dexrazoxane carries some risks, researchers study it for its potential to prevent heart problems during cancer treatment. Discuss any concerns with a doctor to understand what this means for individual circumstances. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Dexrazoxane is unique because it is designed to protect the heart from damage caused by chemotherapy, which is a common treatment for blood cancer. While many current treatments focus on attacking the cancer cells themselves, Dexrazoxane acts as a cardioprotective agent, reducing the harmful side effects of chemotherapy on the heart. This is especially important because heart damage is a serious concern for blood cancer patients undergoing chemotherapy, and Dexrazoxane offers a way to mitigate these risks. Researchers are excited about this treatment because it has the potential to improve the quality of life for patients by allowing them to continue receiving effective cancer treatment without compromising their heart health.

What evidence suggests that dexrazoxane hydrochloride might be an effective treatment for preventing heart-related side effects in blood cancer patients?

Research has shown that dexrazoxane hydrochloride helps reduce heart problems caused by chemotherapy. In studies involving over 1,100 patients, dexrazoxane significantly lowered the risk of heart issues. Specifically, one study found that patients taking dexrazoxane had a 78% lower chance of developing heart failure compared to those who didn't take it. This indicates that dexrazoxane can protect the heart during cancer treatment. It also reduced the occurrence of heart problems from 39% to 13% in people receiving certain chemotherapy drugs. In this trial, participants will receive supportive care with dexrazoxane hydrochloride alongside chemotherapy to evaluate its effectiveness in preventing heart damage during treatment for blood cancers. These findings suggest that dexrazoxane is a promising option for preventing heart damage in people undergoing chemotherapy for blood cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

Maro Ohanian

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain blood cancers like acute myeloid leukemia or chronic myeloid leukemia, who haven't had more than three cycles of chemotherapy. They should have a heart function test showing normal results and agree to use contraception. It's not for those with severe heart disease, recent heart attacks, uncontrolled psychiatric illness, known allergies to the drugs used in the study, or women who are pregnant or breastfeeding.

Inclusion Criteria

Creatinine < 1.5 x ULN

A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial

My blood cancer is in an advanced stage.

Exclusion Criteria

Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk

Patient with documented hypersensitivity to any of the components of the chemotherapy program

I have not had a recent heart attack or severe heart issues in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive gemtuzumab ozogamicin, cladribine, dexrazoxane hydrochloride, idarubicin, and cytarabine. Treatment repeats every 3-7 weeks for up to 2 courses.

6 months

Consolidation

Participants receive gemtuzumab ozogamicin, cladribine, dexrazoxane hydrochloride, idarubicin, and cytarabine. Treatment repeats every 3-7 weeks for up to 6 courses.

6 months

Maintenance

Participants in remission receive gemtuzumab ozogamicin, dexrazoxane hydrochloride, idarubicin, and cytarabine. Courses repeat every 3-7 weeks for 32 months.

32 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Dexrazoxane Hydrochloride

Trial Overview

The trial is testing dexrazoxane hydrochloride's ability to prevent heart damage from chemotherapy in patients with various blood cancers. Participants will receive standard chemo drugs along with dexrazoxane to see if it reduces cardiac side effects compared to usual care without dexrazoxane.

How Is the Trial Designed?

Group I: Supportive care (dexrazoxane hydrochloride, chemotherapy) Experimental Treatment 5 Interventions

See detailed description.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Dexrazoxane (DZR) effectively protects against doxorubicin (DOX)-induced cardiotoxicity in both young and mature rats, showing significant cardioprotective activity at all time points examined during the study.

The study demonstrated that DZR mitigates adverse effects on liver and kidney weights, as well as serum cholesterol and triglycerides, indicating its potential safety and efficacy in reducing the harmful side effects of DOX treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection against doxorubicin-induced cardiotoxicity in weanling rats by dexrazoxane. Della Torre, P., Mazué, G., Podestà, A., et al.[2013]

In a study of 158 children treated with anthracyclines, the use of dexrazoxane was associated with a lower incidence of reduced left ventricular function, showing a significant protective effect over time, especially 5 years post-therapy (2.4% in the dexrazoxane group vs. 11.0% in the control group).

Dexrazoxane appears to significantly reduce the risk of anthracycline-induced cardiotoxicity, as indicated by a decrease in abnormal left ventricular function and wall diameter, although longer follow-up is needed for definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Subacute cardiotoxicity caused by anthracycline therapy in children: can dexrazoxane prevent this effect?]. Erlaky, H., Tóth, K., Szabolcs, J., et al.[2013]

Dexrazoxane is an effective cardioprotective agent that significantly reduces the risk of anthracycline-induced congestive heart failure and other cardiac events in cancer patients, particularly in women with advanced breast cancer and adults with soft tissue sarcomas or small-cell lung cancer.

The use of dexrazoxane does not appear to affect the antitumor efficacy of anthracyclines, making it a valuable option for preventing cardiotoxicity without compromising cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexrazoxane : a review of its use for cardioprotection during anthracycline chemotherapy. Cvetković, RS., Scott, LJ.[2018]

In a study involving Sprague-Dawley rats, dexrazoxane (DZR) significantly reduced infarct size and improved cardiac function after myocardial infarction, indicating its cardioprotective effects.

DZR treatment was associated with increased capillary density and bone marrow-derived endothelial progenitor cells, suggesting that its mechanism of action may involve promoting neovascularization and reducing apoptosis in heart tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardioprotective effect of dexrazoxane in a rat model of myocardial infarction: anti-apoptosis and promoting angiogenesis. Zhou, L., Sung, RY., Li, K., et al.[2013]

In a study of 108 childhood cancer survivors, dexrazoxane significantly reduced the risk of late anthracycline-induced cardiotoxicity, with only 5% of patients receiving cardioprotection showing a decline in heart function compared to 15% in those without it.

The use of dexrazoxane did not negatively impact chemotherapy response rates or overall survival, indicating it is a safe option for protecting heart health in young patients treated for hematological malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late anthracycline cardiotoxicity protection by dexrazoxane (ICRF-187) in pediatric patients: echocardiographic follow-up. Elbl, L., Hrstkova, H., Tomaskova, I., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov/articles/PMC4168851/

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In seven randomized controlled studies including 1,167 patients, cardiac events were significantly reduced with dexrazoxane (risk reduction =0.35 [95% ...

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jacc.org/doi/10.1016/j.jaccao.2024.02.004

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In this population, dexrazoxane reduced the risk of HF (risk ratio: 0.22; 95% CI: 0.11-0.43) with no significant difference in oncologic ...

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ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK560559/

Dexrazoxane - StatPearls - NCBI Bookshelf - NIH

The common side effects that culminate from dexrazoxane use include dose-limiting myelotoxicity (neutropenia, leukopenia, granulocytopenia, and ...

4.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(19)57561-5/fulltext

Multicenter randomized phase III study of the ...

Results: Compared with those receiving anthracycline alone, patients treated with dexrazoxane experienced significantly fewer cardiac events (39% versus 13%, P ...

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accessdata.fda.gov/drugsatfda_docs/label/2014/020212s017lbl.pdf

ZINECARD® (dexrazoxane) for injection - accessdata.fda.gov

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mayoclinic.org/drugs-supplements/dexrazoxane-intravenous-route/description/drg-20063392

Dexrazoxane (intravenous route) - Side effects & uses

This medicine may increase your risk for certain cancers, including acute myeloid leukemia and myelodysplastic syndrome. Talk to your doctor ...

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rxlist.com

rxlist.com/zinecard-drug.htm

Zinecard (Dexrazoxane): Side Effects, Uses, Dosage ...

Zinecard (dexrazoxane) is a cardioprotective agent that is used to protect the heart from harmful side effects caused by doxorubicin.

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/022025s019lbl.pdf

Totect (dexrazoxane - accessdata.fda.gov

With extravasation, grade 2-4 decreased white blood cells (73%), decreased neutrophils (61%), and decreased platelets (26%) occurred in patients treated with ...

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drugs.com

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Dexrazoxane Side Effects: Common, Severe, Long Term

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Dexrazoxane (Zinecard®, Totect®)

Possible Side Effects of Dexrazoxane · Low White Blood Cell Count (Leukopenia or Neutropenia) · Low Red Blood Cell Count (Anemia) · Low Platelet ...