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Taking people in Puerto RicoNo phase

Studies blood samples from patients getting dexrazoxane to learn about heart effects

Looks at blood samples from people given dexrazoxane to study heart-related markers.

Key facts

Who runs it
Children's Oncology Group
Where
San Juan, Puerto RicoSee the siteAlso in 3 other countries, 78 sites
Trial code
Registry title
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
Status
Recruiting
People taking part
420 people, planned
Started
5 Mar 2014
Expected to end
31 Dec 2026
Type of study
Observational
Treatments tested
  • Assessment of Therapy Complications
  • Laboratory Biomarker Analysis
  • Quality-of-Life Assessment
  • Questionnaire Administration
Record updated
18 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who had cancer as children or young adults (leukemia, lymphoma or osteosarcoma) and were treated with anthracycline drugs. Some have a weak heart muscle. It studies blood markers linked to heart problems after cancer treatment.

Age
Stratum IV: cancer diagnosed before age 21. Osteosarcoma comparison subjects: younger than 31 at diagnosis. No other age range is stated.
Sex
All sexes can join.
Disease stage
Leukemia, lymphoblastic lymphoma or Hodgkin lymphoma in first remission (Stratum I); relapse or a later cancer (Stratum II); osteosarcoma without metastasis, moderate or high grade (Stratum III); cancer survivors with weak heart pumping on echocardiogram (Stratum IV).
Earlier treatment
Earlier treatment on trials P9404, P9425, P9426, DFCI 95-01 or P9754 (Strata I to III). Osteosarcoma comparison subjects had 450 to 600 mg/m^2 of doxorubicin and no dexrazoxane (DRZ). Stratum IV: chemotherapy and/or radiotherapy, then alive at least 1 year after treatment.
Biomarker or test result
Stratum IV: on echocardiogram, left ventricular fractional shortening =< 28.0% or ejection fraction =< 50.0% on at least two occasions (or once, with long-term heart medicine for at least 6 months).

Main reasons for not taking part

  • Stratum I: a later cancer that needed more heart-toxic treatment, such as chest radiotherapy or more anthracyclines
  • Stratum I: progressive disease or induction failure needing off-protocol therapy, including hematopoietic cell transplantation
  • Stratum III comparison subjects: low grade, parosteal or periosteal osteosarcoma
  • Stratum III comparison subjects: any anthracycline other than doxorubicin, or any past exposure to DRZ
  • Stratum IV: known congenital heart disease or a genetic syndrome affecting the heart, such as Down syndrome

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Study Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV
  • STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS
  • Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)
  • STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia/lymphoblastic lymphoma [P9404, high-risk DFCI 95-01] or Hodgkin lymphoma [P9425/P9426])
  • STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation
  • STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest [also includes fields directed towards the neck, upper abdomen, or spine], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible
  • STRATUM I: All patients and/or their parents or legal guardians must sign a written informed consent
  • STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's [COG?s] Statistics and Data Center [SDC] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse/subsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)
  • STRATUM II: Alive, but have experienced relapse of their original cancer and/or have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis
  • STRATUM II: All patients and/or their parents or legal guardians must sign a written informed consent
  • STRATUM III: OSTEOSARCOMA SURVIVORS
  • Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and/or parents/legal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors
  • Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:; Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible; < 31 years of age at time of initial osteosarcoma diagnosis; Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002; No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction >= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction >= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis; Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg/m\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria; No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies; No exposure to DRZ at any point in time; All patients and/or their parents or legal guardians must sign a written informed consent
  • STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3
  • Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and/or radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year
  • Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine [DICOM] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable
  • Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)
  • Based on echocardiography, must have either left ventricular fractional shortening =< 28.0% or ejection fraction =< 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection
  • If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme [ACE]-inhibitor, angiotensin receptor blocker) lasting at least 6 months
  • For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Where in Puerto Rico

Also in 3 other countries, 78 sites

  • San Jorge Children's HospitalSan Juan, Puerto RicoContact: Luis A. Clavell (principal investigator)Taking people

About the trial

What the trial wants to find out

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

The group in the trial

  • Ancillary-Correlative (laboratory biomarker analysis)

    Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires.

    Treatment: Assessment of Therapy Complications, Laboratory Biomarker Analysis, Quality-of-Life Assessment, and Questionnaire Administration

Results explained

A paper that names this trial, explained in plain words.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy
Plain-language title
Studies blood samples from patients getting dexrazoxane to learn about heart effectsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
18 May 2026