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Heart shield for young cancer survivors: new study tests dexrazoxane

NCT ID NCT01790152

Disease control Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a drug called dexrazoxane can help prevent heart damage in children and teens who have been treated for certain cancers like leukemia, lymphoma, and osteosarcoma. Researchers will measure heart function and blood markers in 420 survivors to see if dexrazoxane reduces the risk of heart failure. The goal is to improve long-term heart health for those who received strong chemotherapy or radiation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2014

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with leukemia or lymphoma enrolled on Pediatric Oncology Group (POG) P9404, P9425, P9426, and DFCI 95-01 or osteosarcoma enrolled on P9754

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

cancer Hodgkins lymphoma leukemia lymphoblastic lymphoma lymphoma osteosarcoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hodgkin lymphoma in remission Leukemia in remission Lymphoblastic lymphoma Osteosarcoma Recurrent leukemia Recurrent lymphoma Recurrent malignant neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    67 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Children's Hospital-Oak Lawn

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Alberta Children's Hospital

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

    Contact Email: •••••@•••••

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    RECRUITING

    Las Vegas, Nevada, 89135, United States

    Contact Email: •••••@•••••

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202-3591, United States

  • Ascension Saint John Hospital

    RECRUITING

    Detroit, Michigan, 48236, United States

  • BI-LO Charities Children's Cancer Center

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Banner University Medical Center - Tucson

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Centre Hospitalier Universitaire de Quebec

    RECRUITING

    Québec, G1V 4G2, Canada

  • Children's Healthcare of Atlanta - Egleston

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Eastern Ontario

    ACTIVE_NOT_RECRUITING

    Ottawa, Ontario, K1H 8L1, Canada

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • Columbia Regional

    ACTIVE_NOT_RECRUITING

    Columbia, Missouri, 65201, United States

  • Cook Children's Medical Center

    SUSPENDED

    Fort Worth, Texas, 76104, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center

    ACTIVE_NOT_RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Golisano Children's Hospital of Southwest Florida

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital for Sick Children

    SUSPENDED

    Toronto, Ontario, M5G 1X8, Canada

  • Hurley Medical Center

    ACTIVE_NOT_RECRUITING

    Flint, Michigan, 48503, United States

  • Johns Hopkins All Children's Hospital

    ACTIVE_NOT_RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Kapiolani Medical Center for Women and Children

    RECRUITING

    Honolulu, Hawaii, 96826, United States

  • Legacy Emanuel Children's Hospital

    RECRUITING

    Portland, Oregon, 97227, United States

  • Lucile Packard Children's Hospital Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Lurie Children's Hospital-Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Maine Children's Cancer Program

    RECRUITING

    Scarborough, Maine, 04074, United States

  • McMaster Children's Hospital at Hamilton Health Sciences

    SUSPENDED

    Hamilton, Ontario, L8N 3Z5, Canada

  • Medical City Dallas Hospital

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75230, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    ACTIVE_NOT_RECRUITING

    Hollywood, Florida, 33021, United States

  • Mission Hospital

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • Nemours Children's Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Hospital

    RECRUITING

    Orlando, Florida, 32827, United States

  • Ochsner Medical Center Jefferson

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Perth Children's Hospital

    RECRUITING

    Perth, Western Australia, 6009, Australia

    Contact Email: •••••@•••••

  • Phoenix Childrens Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Princess Margaret Hospital for Children

    ACTIVE_NOT_RECRUITING

    Perth, Western Australia, 6008, Australia

  • Providence Sacred Heart Medical Center and Children's Hospital

    RECRUITING

    Spokane, Washington, 99204, United States

  • Rady Children's Hospital - San Diego

    RECRUITING

    San Diego, California, 92123, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Roswell Park Cancer Institute

    SUSPENDED

    Buffalo, New York, 14263, United States

  • Saint Christopher's Hospital for Children

    RECRUITING

    Philadelphia, Pennsylvania, 19134, United States

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    RECRUITING

    Tampa, Florida, 33607, United States

  • Saint Jude Midwest Affiliate

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Saint Mary's Hospital

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • San Jorge Children's Hospital

    RECRUITING

    San Juan, 00912, Puerto Rico

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Sinai Hospital of Baltimore

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • State University of New York Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Stony Brook University Medical Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Summerlin Hospital Medical Center

    RECRUITING

    Las Vegas, Nevada, 89144, United States

    Contact Email: •••••@•••••

  • Sunrise Hospital and Medical Center

    RECRUITING

    Las Vegas, Nevada, 89109, United States

    Contact Email: •••••@•••••

  • The Montreal Children's Hospital of the MUHC

    RECRUITING

    Montreal, Quebec, H3H 1P3, Canada

    Contact Email: •••••@•••••

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • University Medical Center of Southern Nevada

    RECRUITING

    Las Vegas, Nevada, 89102, United States

    Contact Email: •••••@•••••

  • University of Florida Health Science Center - Gainesville

    SUSPENDED

    Gainesville, Florida, 32610, United States

  • University of Hawaii Cancer Center

    ACTIVE_NOT_RECRUITING

    Honolulu, Hawaii, 96813, United States

  • University of Illinois

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • University of Vermont and State Agricultural College

    RECRUITING

    Burlington, Vermont, 05405, United States

  • Valley Children's Hospital

    ACTIVE_NOT_RECRUITING

    Madera, California, 93636, United States

  • Virginia Commonwealth University/Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Wayne State University/Karmanos Cancer Institute

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48201, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

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