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Hodgkin Lymphoma in RemissionNCT01790152

Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment

An observational study of Hodgkin Lymphoma in Remission and Leukemia in Remission, run by Children's Oncology Group at 79 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
What is being tested?
Assessment of Therapy Complications, Laboratory Biomarker Analysis and Quality-of-Life Assessment
How many people
420 participants
Where
79 sitesin 4 countries
Study dates
5 Mar 2014to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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
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  • 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

Who cannot join

None listed.

Trial locations and contacts

79 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

79 sites in 4 countries

United States69 sites, 56 recruiting

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

    Site Public Contact, 330-543-3193

    Steven J. Kuerbitz

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

    Site Public Contact, 505-925-0366, LByatt@nmcca.org

    John F. Kuttesch

    Recruiting

  • Mission Hospital

    Asheville, North Carolina, 28801

    Site Public Contact, 828-213-2539, Karen.Smith3@HCAHealthcare.com

    Douglas J. Scothorn

    Recruiting

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia, 30322

    Site Public Contact, 404-785-2025, Leann.Schilling@choa.org

    Lillian R. Meacham

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Site Public Contact, 410-601-6120, pridgely@lifebridgehealth.org

    Jason M. Fixler

    Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

    Kenneth J. Cohen

    Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

    Site Public Contact, 205-638-9285, oncologyresearch@peds.uab.edu

    Smita Bhatia

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Lynda M. Vrooman

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Suspended

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Jessica L. Heath

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Jacqueline M. Kraveka

    Recruiting

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

    Site Public Contact, 773-880-4562

    Jennifer L. Reichek

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Active, not recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Site Public Contact, 513-636-2799, cancer@cchmc.org

    Rajaram Nagarajan

    Recruiting

  • Columbia Regional

    Columbia, Missouri, 65201

    Active, not recruiting

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

    Active, not recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Daniel C. Bowers

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Active, not recruiting

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Adonis N. Lorenzana

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Saro H. Armenian

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Active, not recruiting

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

    Site Public Contact, 239-343-5333, molly.arnstrom@leehealth.org

    Emad K. Salman

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Suspended

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

    Suspended

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-2066, kim.williams3@prismahealth.org

    Nichole L. Bryant

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Site Public Contact, 201-996-2879

    Michael B. Harris

    Recruiting

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Active, not recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

    Active, not recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    Wade T. Kyono

    Recruiting

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

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Julienne Brackett

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Site Public Contact, 601-815-6700

    Anderson (Andy) B. Collier

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

    Site Public Contact, 904-697-3529

    Ramamoorthy Nagasubramanian

    Recruiting

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Active, not recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

    Site Public Contact, 501-364-7373

    David L. Becton

    Recruiting

  • Valley Children's Hospital

    Madera, California, 93636

    Active, not recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-955-4727, MACCCTO@mcw.edu

    Richard L. Tower

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Nina S. Kadan-Lottick

    Recruiting

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

    New Hyde Park, New York, 11040

    Site Public Contact, 718-470-3460

    Jonathan D. Fish

    Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

    Site Public Contact, 504-703-8712, Gregory.Johnstone@ochsner.org

    Craig Lotterman

    Recruiting

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois, 60453

    Site Public Contact, 847-723-7570

    Rebecca E. McFall

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Laura A. Campbell

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Rene Y. McNall-Knapp

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, 32827

    Site Public Contact, 407-650-7150

    Ramamoorthy Nagasubramanian

    Recruiting

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

    Site Public Contact, 800-694-0012, ccto-office@stanford.edu

    Jay Michael S. Balagtas

    Recruiting

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

    Site Public Contact, 888-226-4343

    Jaime M. Libes

    Recruiting

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

    Site Public Contact, 215-427-8991

    Gregory E. Halligan

    Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

    Site Public Contact, 602-546-0920

    Alexandra M. Walsh

    Recruiting

  • Legacy Emanuel Children's Hospital

    Portland, Oregon, 97227

    Site Public Contact, 503-413-2560

    Janice F. Olson

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Susan J. Lindemulder

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Site Public Contact, 401-444-1488

    Jennifer J. Greene Welch

    Recruiting

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-1914, klcampbell@vcu.edu

    Madhu S. Gowda

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Angela R. Girvin

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu

    Anne-Marie R. Langevin

    Recruiting

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

    Site Public Contact, 858-966-5934

    William D. Roberts

    Recruiting

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-7581, sverwys@mmc.org

    Eric C. Larsen

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Site Public Contact, 866-987-2000

    Douglas S. Hawkins

    Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

    Site Public Contact, 800-228-6618, HopeBeginsHere@providence.org

    Judy L. Felgenhauer

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Robert J. Hayashi

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

    Active, not recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Site Public Contact, 800-862-2215

    Laura E. Hogan

    Recruiting

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Site Public Contact, 315-464-5476

    Philip M. Monteleone

    Recruiting

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

    Tampa, Florida, 33607

    Site Public Contact, 813-356-7168, Katelynn.Colgain@baycare.org

    Dana A. Obzut

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, aselegue@email.arizona.edu

    Holly E. Pariury

    Recruiting

  • Saint Mary's Hospital

    West Palm Beach, Florida, 33407

    Site Public Contact, 561-881-2815

    Narayana Gowda

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    Thomas B. Russell

    Recruiting

Other trials in United States

Canada7 sites, 4 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Site Public Contact, 403-220-6898, research4kids@ucalgary.ca

    Douglas R. Strother

    Recruiting

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

    Suspended

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3

    Site Public Contact, 514-412-4445, info@thechildren.com

    Sharon B. Abish

    Recruiting

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Site Public Contact, 514-345-4931

    Yvan Samson

    Recruiting

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

    Active, not recruiting

  • Centre Hospitalier Universitaire de Quebec

    Québec, G1V 4G2

    Site Public Contact, 418-525-4444

    Bruno Michon

    Recruiting

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Suspended

Other trials in Canada

Australia2 sites, 1 recruiting

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6008

    Active, not recruiting

  • Perth Children's Hospital

    Perth, Western Australia, 6009

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Marianne B. Phillips

    Recruiting

Other trials in Australia

Puerto Rico1 site, 1 recruiting

  • San Jorge Children's Hospital

    San Juan, 00912

    Site Public Contact, 787-727-1000

    Luis A. Clavell

    Recruiting

Other trials in Puerto Rico

About this study

Official title: Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and Dana Farber Cancer Institute (DFCI) 95-01 randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm.

II. To determine whether osteosarcoma patients from P9754 (all received DRZ) have decreased markers of cardiomyopathy/heart failure (CHF) compared with similarly treated osteosarcoma patients diagnosed during the same time period, but who did not receive DRZ.

III. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex).

SECONDARY OBJECTIVES:

  1. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and DFCI 95-01 on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms.

II. To determine whether projected quality-adjusted life years (QALY) differed by DRZ status, accounting for premature cardiac disease, primary disease relapse, and second cancers.

III. Determine the longitudinal trajectory of 2-dimensional echocardiographic parameters (focusing on left ventricular [LV] function and remodeling/geometric changes that can be reliably re-measured) among patients from time of cancer treatment through subsequent follow-up.

OUTLINE:

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.

Being tested
Assessment of Therapy Complications, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Osteosarcoma, Leukemia, Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of Therapy ComplicationsOther

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT01790152
Study groupRoleWhat they receive
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.
Receives: Other: Assessment of Therapy Complications; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram

    Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.

    Measured: Baseline

  2. Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides)

    Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.

    Measured: Baseline

Secondary outcomes (4)

  1. Quality of life based on self-report instruments

    An analytic Markov model will be created and used. Estimates and their 95% confidence will be included to explore the sensitivity of any quality-adjusted life years estimates.

    Measured: Baseline

  2. Primary disease relapse

    An analytic Markov model will be created and used.

    Measured: Baseline

  3. Second cancer rates

    An analytic Markov model will be created and used.

    Measured: Baseline

  4. Longitudinal trajectory of 2-dimensional echocardiographic parameters

    Will utilize generalized linear model-general estimation equation to model the trajectories of echocardiographic biomarker estimates (continuous outcomes) across time. Relevant model shapes will be evaluated, beginning with linear models, but also testing more flexible shapes (e.g., quadratic, cubic, or cubic spline functions with varying numbers of knots) to determine whether non-linear components are needed for fit. Will also examine interactions of dexrazoxane (DRZ) status with the selected functions of time to evaluate for differences in trajectories over time by DRZ status.

    Measured: From time of cancer treatment to subsequent follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study start5 Mar 2014
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01790152
Sponsor's protocol ID
ALTE11C2
Other IDs
S0004187, ALTE11C2, COG-ALTE11C2, ALTE11C2, R01CA211996, U10CA095861, UG1CA189955
Status last verified
May 2026
First submitted
11 Feb 2013
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No

Publications

  • Chow EJ, Aggarwal S, Doody DR, Aplenc R, Armenian SH, Baker KS, Bhatia S, Blythe N, Colan SD, Constine LS, Freyer DR, Kopp LM, Laverdiere C, Leisenring WM, Sasaki N, Vrooman LM, Asselin BL, Schwartz CL, Lipshultz SE. Dexrazoxane and Long-Term Heart Function in Survivors of Childhood Cancer. J Clin Oncol. 2023 Apr 20;41(12):2248-2257. doi: 10.1200/JCO.22.02423. Epub 2023 Jan 20.

    PubMed 36669148

  • Lipshultz ER, Chow EJ, Doody DR, Armenian SH, Asselin BL, Baker KS, Bhatia S, Constine LS, Freyer DR, Kopp LM, Schwartz CL, Lipshultz SE, Vrooman LM. Cardiometabolic Risk in Childhood Cancer Survivors: A Report from the Children's Oncology Group. Cancer Epidemiol Biomarkers Prev. 2022 Mar 1;31(3):536-542. doi: 10.1158/1055-9965.EPI-21-0360.

    PubMed 34810210

  • Chow EJ, Aplenc R, Vrooman LM, Doody DR, Huang YV, Aggarwal S, Armenian SH, Baker KS, Bhatia S, Constine LS, Freyer DR, Kopp LM, Leisenring WM, Asselin BL, Schwartz CL, Lipshultz SE. Late health outcomes after dexrazoxane treatment: A report from the Children's Oncology Group. Cancer. 2022 Feb 15;128(4):788-796. doi: 10.1002/cncr.33974. Epub 2021 Oct 13.

    PubMed 34644414

  • Mobley EM, Doody DR, Colan SD, Aggarwal S, Aplenc R, Armenian SH, Baker KS, Bhatia S, Constine LS, Freyer DR, Kopp LM, Leisenring WM, Sasaki N, Vrooman LM, Asselin BL, Schwartz CL, Chow EJ, Lipshultz SE. Longitudinal Change in Cardiac Function After Doxorubicin and Dexrazoxane: A Report From Children's Oncology Group ALTE11C2. J Clin Oncol. 2026 Oct;44(28):2680-2689. doi: 10.1200/JCO-26-00260. Epub 2026 Aug 6.

    PubMed 42561216

  • Chow EJ, Asselin BL, Schwartz CL, Doody DR, Leisenring WM, Aggarwal S, Baker KS, Bhatia S, Constine LS, Freyer DR, Lipshultz SE, Armenian SH. Late Mortality After Dexrazoxane Treatment: A Report From the Children's Oncology Group. J Clin Oncol. 2015 Aug 20;33(24):2639-45. doi: 10.1200/JCO.2014.59.4473. Epub 2015 May 26.

    PubMed 26014292

Questions about this trial

What is this clinical trial studying?

An observational study of Hodgkin Lymphoma in Remission and Leukemia in Remission, run by Children's Oncology Group at 79 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Canada, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01790152, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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